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« on: May 09, 2006, 04:58:22 pm »

Neuropathic Pain: An Update on Effective Management Strategies

Introduction
Pain adversely affects millions of people every year, impacting their physical and emotional functioning, diminishing quality of life, and reducing functional capabilities. Chronic pain frequently results in absenteeism from work (about 50 million lost workdays each year), as well as "presenteeism," which is defined as reduced productivity at work.[1] Up to 40% of the US population experiences chronic pain annually, and at least 4 out of 10 chronic pain patients do not achieve adequate pain relief.[2,3]

Many common medical conditions are associated with pain, including cancer, sickle-cell disease, arthritis, low-back problems, diabetes, headache, multiple sclerosis, spinal cord disorders, infectious diseases (eg, herpes zoster, AIDS), cerebrovascular accidents, and others. Pain is frequently accompanied by comorbid conditions such as anxiety and depressive disorders, and patients with persistent pain are more likely to have unfavorable health perceptions compared with patients not experiencing pain.[4]

Pharmacists frequently interact with patients suffering from chronic pain, and thus are in an excellent position to participate in their management plans. The etiology and management of chronic pain were discussed in sessions at the recent annual meeting of the American Pharmacists Association, held March 17-21, 2006, in San Francisco.

Categorizing Pain
Pain can be categorized in many different ways. For example, we can compare and contrast acute vs chronic pain, or malignant vs nonmalignant pain, or we can consider the pathogenesis of the pain. One noted pain researcher has classified pain as adaptive (protecting the body from injury or injury progression) or maladaptive (pain as disease).[5]

Adaptive pain includes nociceptive pain and inflammatory pain. Nociception is the term used to describe the processing of stimuli that damage normal tissue (or may do so with continued exposure to the stimulus) into a conscious pain experience. Clearly, nociceptive pain has some value, because it serves as an early warning system of potential injury from a damaging stimulus.

There are 4 steps in the nociceptive process: transduction (the conversion of a noxious stimulus into electrical activity in the afferent primary peripheral neurons); transmission (moving the neural impulse from the site of transduction to the brain); perception (interpreting the neural impulse relayed from the periphery as pain); and modulation (changing or inhibiting the pain impulse).

Inflammatory pain occurs when the body shifts its attention to healing the injured tissue. For example, the injured area is far more sensitive to further injury, and the person is motivated to protect the damaged area. If you had a broken arm, you would inherently protect the injured arm from further injury, and any stimulus (eg, touch or pressure) would readily evoke pain as a protective mechanism.

Neuropathic pain is a prime example of maladaptive pain. The International Association for the Study of Pain (IASP) has defined neuropathic pain as "pain initiated or caused by a primary lesion or dysfunction of the nervous system."[6] These lesions may be in the peripheral or central nervous system, and frequently both systems are involved with chronic neuropathic pain states. Many commonly experienced persistent pain states are partially or completely neuropathic in nature. Examples include phantom limb and spinal cord injury pain, painful diabetic neuropathy, postherpetic neuralgia, sciatica, trigeminal neuralgia, and drug-induced (eg, vinca alkaloids) neuropathy.

Backonja[7] defines neuropathic pain and differentiates it from other types of pain as follows:

Pain and sensory symptoms that persist beyond the healing period.

Presence, in variable degree, of neurological sensory signs manifesting as negative and positive sensory phenomena.

Presence, in variable degree, of other neurological signs, including motor, manifesting as negative and positive motor phenomena or autonomic signs.
Reference to the presence of negative and positive sensory phenomena indicates abnormal sensations that are seen on physical exam. Neuropathic pain may be "stimulus-evoked" by light touch, pressure of clothing or bedding, or either hot or cold temperatures. Pain in response to a nonpainful stimulus is referred to as "allodynia." An exaggerated pain response to a painful stimulus (eg, a pinprick) is termed "hyperalgesia."[8] Patients also may complain of hypoesthesia (diminished sensation), paresthesia (an abnormal sensation), or dysesthesia (an unpleasant abnormal sensation).[8]

Spontaneous neuropathic pain is usually described by the patient as a constant burning, plus intermittent pain that may be described as "shooting" or "electric shock-like." Patients with painful diabetic neuropathy, for example, frequently describe the pain as though they were "walking on broken glass," "buzzing," or feeling the sensation of bugs crawling on their feet.

Negative sensory phenomena refer to loss of sensation, such as loss of feeling secondary to pinprick, thermal, tactile, or vibratory sensation. For patients with diabetic neuropathy, it is important to explain the importance of the loss of this protective sensation.

So what pathophysiologic changes occur to produce symptomatic, persistent neuropathic pain? Changes may occur in both the peripheral and central nervous systems.[5,9]

Changes in the peripheral nervous system include the following:

Ectopic discharge and ephaptic conduction. After nerve injury, there is an increase in the level of spontaneous firings from newly formed nerve sprouts, or neuromas, which have grown from the injured nerve. This ectopic activity is likely due to changes in the sodium channels. After some period of time, atypical connections may develop between the nerve sprouts and neighboring afferent neurons, leading to "ephaptic conduction" or "cross-talk" between neurons. Therefore, pain that results from peripheral nerve damage may originate in injured or intact sensory neurons.


Alterations in ion channel expression. Sodium channels are critical to the physiology of excitable membranes, such as neurons, and are likely increased in number and density with neuronal damage. Calcium channels may also be affected with peripheral nerve injury.


Other causes of peripheral sensitization include heightened responsiveness to inflammatory mediators released by damaged cells, collateral sprouting of primary afferent neurons, and sprouting of sympathetic neurons in the dorsal root ganglion.
Changes in the central nervous system, referred to as "central sensitization," include the following mechanisms[5,9-11]:

Just as it takes less stimulus to evoke pain in the periphery, a similar phenomenon is seen centrally. Central sensitization amplifies and facilitates the synaptic transfer from primary afferent neurons to secondary neurons in the dorsal horn. This phenomenon is sometimes referred to as "wind-up," which is characterized by an increasing response to repeated input from C-fibers resulting in enhanced spinal cord excitability.


Some studies suggest that glutamate acts in the spinal cord and at supraspinal sites at excitatory amino acid receptors (eg, N-methyl-D-aspartate [NMDA]) to amplify sensory input from the periphery.


The gamma-aminobutyric acid (GABA) pathway is an inhibitory neurotransmitter system in the central nervous system, and its suppression is associated with neuropathic pain.


Research has also shown that there is likely upregulation of the calcium channel in the central nervous system with nerve damage, particularly the alpha-2-delta subunit.
After peripheral nerve injury, there is considerable reorganization of the spinal cord. With normal physiology, myelinated A-delta fibers and unmyelinated C-fibers (that transmit the pain impulse) terminate in the superficial laminae (I and II) of the dorsal horn. Low-threshold sensory fibers (eg, A-beta fibers) that are activated by pressure, vibration, touch, and normal temperature exposure terminate in the deep laminae of the dorsal horn (eg, laminae III and IV). Within several weeks of nerve damage, new growth of the central terminals of the low-threshold afferents (sensory fibers) terminate where the pain impulse neurons usually terminate exclusively. This pathophysiologic change explains how the normal sensation of touch can be perceived as pain.

Treatment of Neuropathic Pain
Pharmacists who attended the APhA annual meeting had an opportunity to attend an educational session titled "Neuropathic Pain." In this session, pharmacists learned about the pathogenesis and clinical presentation of neuropathic pain, as well as treatment options.

When considering pharmacologic options to treat chronic pain, we first think of nonopioids (eg, acetaminophen, nonsteroidal anti-inflammatory agents), opioids, and co-analgesics. Generally speaking, the nonopioids are unlikely to provide any significant degree of pain relief in patients with neuropathy. Given the complicated nature of neuropathic pain, it is not surprising to find that, at best, an opioid or co-analgesic agent will effect a 30% reduction in the pain severity rating. In fact, this response is considered to be "clinically important" and, at this level, patients will report "moderate relief" or say they are "much improved." The medications used to treat neuropathic pain commonly cause adverse effects and are frequently involved in drug interactions. Careful analgesic selection and dosage titration are required, as many patients with neuropathic pain are elderly, take multiple medications, and have numerous comorbid conditions.

At present there are only 5 co-analgesic agents that carry US Food and Drug Administration (FDA)-approved indications for neuropathic pain. These are carbamazepine (Tegretol [Novartis]) for trigeminal neuralgia, gabapentin (Neurontin [Parke-Davis]) and transdermal lidocaine (LidoDerm [Endo]) for postherpetic neuralgia, duloxetine (Cymbalta [Eli Lilly]) for diabetic neuropathy, and pregabalin (Lyrica [Pfizer]) for both diabetic neuropathy and postherpetic neuralgia. However, there is a significant body of literature demonstrating the effectiveness of these and other co-analgesics in treating a wide variety of neuropathic pain states.

Robert Dworkin and colleagues[12] considered the evidence base of analgesics and co-analgesic clinical trials in the management of neuropathic pain. They concluded that first-line recommendations included gabapentin, the 5% lidocaine transdermal patch, opioid analgesics, tramadol hydrochloride, and tricyclic antidepressants (TCAs). Since that time, Dworkin has published further reports that add the serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressants (eg, venlafaxine and duloxetine) and pregabalin as first-line medications for neuropathic pain.[13]

Alpha2-Delta Ligands
Gabapentin was the first alpha2-delta ligand introduced to the market as an antiepileptic drug. At least 8 clinical trials have shown gabapentin to be effective in treating a variety of neuropathic pain states, including postherpetic neuralgia, painful diabetic neuropathy, mixed neuropathic pain syndromes, phantom limb pain, Guillain-Barré syndrome, and spinal cord injury pain.

Adverse effects associated with gabapentin therapy include somnolence, dizziness, gait and balance problems, and, less frequently, gastrointestinal complaints and peripheral edema. To maximize tolerability and acceptance of gabapentin therapy, it is vital that the practitioner start at a low dose (eg, 100 mg qhs to 300 mg qhs) and titrate upward. After starting with a single bedtime dose, increase to twice-daily dosing, then to 3 times daily. Keeping the 3 times daily dosing interval, increase the total daily dose as tolerated, making adjustments every 1-7 days as tolerated by the patient. It may take several weeks to get to the target dose for an individual patient, and this may range from 1800 to 3600 mg per day.

Pregabalin is another alpha2-delta ligand that is closely related to gabapentin. Not surprisingly, pregabalin has adverse effects that are quite similar to those seen with gabapentin, although patients seem to tolerate more rapid dosage titration. The recommended starting dose is either 50 mg 3 times daily or 75 mg twice daily, with titration to 300 mg daily after several days. Dosage of both gabapentin and pregabalin should be adjusted in patients with renal impairment.

Opioid Analgesics
Opioid analgesics have been the backbone of management of moderate to severe pain for thousands of years. Of interest, opioids have been unfairly maligned as ineffective analgesics for the management of neuropathic pain. Several double-blind, randomized clinical trials published in the last decade have demonstrated the effectiveness of opioids in treating a variety of neuropathic pain conditions such as postherpetic neuralgia, painful diabetic neuropathy, and a variety of mixed peripheral and central neuropathic pain syndromes. Using opioids adjunctively with other co-analgesics, both at lower doses, has also been an effective strategy. For example, a study recently published in The New England Journal of Medicine[14] showed the combination of morphine plus gabapentin was more effective than either drug alone at higher doses.

The most common adverse effects associated with opioid therapy include constipation (to which tolerance will not develop), nausea, sedation, and confusion. All patients taking opioids chronically will develop some physical dependence, so therapy cannot be stopped abruptly. However, in patients with no previous history of drug abuse or diversion, psychological dependence is unlikely to develop when using these agents to treat chronic pain.

Some practitioners recommend starting with a short-acting opioid and switching to a longer-acting opioid once the effective daily dose is reached. Others begin with the lowest dose of a long-acting opioid and titrate accordingly. Oral long-acting opioids include morphine (MS Contin [Purdue Frederick], Kadian [Alpharma], Avinza [Ligand], and generic long-acting), oxycodone (OxyContin [Purdue Frederick] and generic long-acting), and methadone (dosed every 8-12 hours for pain control). Transdermal fentanyl is also available, and the patch is usually changed every 72 hours (some patients require that it be changed every 48 hours). Caution is advised with "combination" analgesics such as hydrocodone plus acetaminophen (Vicodin [Abbott] or Lortab [UCB Pharma]) or oxycodone plus acetaminophen (Percocet [Endo]). Even though there is no ceiling dose for the opioid component, the total daily acetaminophen dose should not exceed 4 grams.

Tramadol
Tramadol (Ultram [Ortho McNeil]; tramadol with acetaminophen as Ultracet [Ortho McNeil]) is a norepinephrine and serotonin reuptake inhibitor that has a weak mu opioid agonist as one of its metabolites. Tramadol is effective in treating painful diabetic neuropathy and polyneuropathy of various causes. Adverse effects include nausea, somnolence, constipation, dizziness, and orthostatic hypotension. Tramadol has also been shown to lower the seizure threshold. Caution should be used with other medications that increase serotonin levels because of an increased risk of serotonin syndrome.

The initial dose should be 50 mg once or twice daily, increased every 3-7 days by 50 to 100 mg. The maximum daily dose is 400 mg in patients younger than 75 years, and 300 mg in older patients. Dosage should be further reduced in renal impairment.

5% Lidocaine Transdermal Patch
There are 2 published clinical trials demonstrating efficacy of the 5% lidocaine transdermal patch in treating postherpetic neuralgia. Additional data have been published on the efficacy of this product in treating osteoarthritis of the knees and for other nonapproved indications.

The FDA-approved dosing schedule is 12 hours on (with patches cut as needed and applied directly to the painful sites) and 12 hours off. With normal hepatic function, blood levels are minimal and the lidocaine does not accumulate. Adverse effects are minimal and include erythema or rash at the application site. The maximum recommended dose is 3 patches worn concurrently.

Tricyclic Antidepressants
TCAs were among the earliest medications shown to have analgesic efficacy as "adjuvants" or "co-analgesics." Early clinical trials used amitriptyline, but later research has demonstrated the effectiveness of other TCAs such as desipramine and nortriptyline, which tend to be better tolerated than amitriptyline. Adverse effects can be considerable with the TCAs and include anticholinergic effects (eg, dry mouth, blurred vision, constipation, urinary retention, and cognitive impairment), sedation, and orthostatic hypotension. Of particular concern are the cardiovascular adverse effects and the risks associated with overdose.

Dosing should begin with 10 mg (older adults) or 25 mg at bedtime, and should be increased every 3-7 days as tolerated. Generally, pain relief is achieved with 75-100 mg per day.

SNRI Antidepressants
The SNRIs are the latest group of co-analgesics used to treat neuropathic pain. Venlafaxine (Effexor [Wyeth]) and duloxetine have both been shown to be efficacious in treating neuropathic pain conditions, although duloxetine is the only SNRI with an FDA-approved indication for neuropathy (painful diabetic neuropathy).

Second-Line Co-analgesics
There are a variety of co-analgesics that could be considered "second-line" beyond those described above. Other antiepileptic agents include the first-generation agents (eg, phenytoin and carbamazepine) and second-generation agents (eg, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, and zonisamide). There are fewer data evaluating the role of these agents in the treatment of neuropathic pain.

The SSRIs have been disappointing in terms of pain relief, although they are better tolerated than the TCAs. Other co-analgesics include capsaicin, clonidine, dextromethorphan, and mexiletene.

Selecting a Co-analgesic Agent
As with the pharmacotherapeutic management of any condition, there are many variables that affect drug therapy selection. Consider comorbid conditions (eg, renal impairment or osteoarthritis), risk factors for adverse effects, age and cognitive status, and financial implications of therapy. Because any one co-analgesic is unlikely to completely relieve the neuropathic pain, some have suggested that combinations of analgesics be selected based on complementary mechanisms of action.

For example, co-analgesics that act to reduce peripheral sensitization are drugs that affect the sodium channels (eg, carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, lidocaine, and mexiletine). Co-analgesics that address central sensitization by affecting calcium channels include gabapentin, pregabalin, levetiracetam, oxcarbazepine, lamotrigine, topiramate, and ziconotide. TCAs, SNRIs, tramadol, and opioids will enhance the descending inhibitory pathway.[15]

The Role of the Pharmacist in Pain Management
Pharmacists are the most frequently encountered member of the healthcare team for ambulatory patients. This fact, coupled with the recent developments in Medicare Part D and the opportunity for pharmacists to provide Medication Therapy Management (MTM) services, makes the pharmacist an ideal professional to address chronic pain problems.

In a session presented by Kathryn Hahn, PharmD, and Mary Lynn McPherson, PharmD, pharmacists learned about pain management and MTM services.[16] MTM services are not new to pharmacists who have been working with patients for years to identify and resolve drug-related problems. However, MTM services are now a required component of the Medicare prescription drug benefit.

"MTM services are independent of, but can occur in conjunction with, dispensing a medication," Dr. Hahn said. "MTM services encompass a broad range of professional activities or responsibilities that are within the licensed pharmacist's scope of practice."

The American Pharmacists Association has worked with the National Association of Chain Drug Stores Foundation to develop 5 "core elements" of MTM services. These include:

Medication Therapy Review: The pharmacist conducts this review with the patient and/or caregiver, usually in a face-to-face encounter.


Personal Medication Record: After reviewing the patient's medication regimen, the pharmacist provides the patient with a personal medication record. The patient is encouraged to share this with all healthcare providers and to bring it on future pharmacist visits.


Medication Action Plan: At the end of the MTM visit, the pharmacist will provide the patient with a medication action plan that contains information for the patient to use in optimizing medication self-management. This plan may include non-drug action items, such as lifestyle modification (eg, diet and exercise).


Intervention and/or Referral: The pharmacist may need to intervene with the prescriber or refer the patient to additional healthcare providers for further care.


Documentation and Follow-Up: The pharmacist will document his or her services in a format that allows patient follow-up. A summary of the patient encounter is also documented and shared with the patient's primary care provider.
As Dr. Hahn informed the audience, MTM services will be reimbursed for eligible patients. Eligibility will be defined by the number of chronic medications the patient is receiving, the number of comorbid conditions, and/or the total annual drug expenditure. These criteria will likely yield a large number of patients from a community pharmacy practice.

Given the high prevalence of pain in our society, patients who meet MTM services criteria likely have pain as a complaint. Pain may not be the patient's primary complaint, but it often is associated with common disease states such as osteoarthritis, diabetes, insomnia, or a variety of conditions for which patients seek nonprescription medications.

Dr. Hahn recommended asking all patients, "Do you have any pain or discomfort that you have not previously mentioned?" Building on this, the pharmacist should determine whether analgesics have been prescribed for the patient in the past and whether the patient is using these medications correctly.

MTM services are a tremendous opportunity for pharmacists, and the ability to intervene on behalf of patients with chronic pain is significant.

References
Fox CD, Berger D, Fine PG. Pain assessment and treatment in the managed care environment: position statement. American Pain Society. Case Manager. 2000;11:50-53.
Verhaak PF, Kerssens JJ, Dekker J, et al. Prevalence of chronic benign pain disorder among adults: a review of the literature. Pain. 1998;77:231-239. Abstract
Phillips DM. JCAHO pain management standards are unveiled. JAMA. 2000;284:428-429. Abstract
Ashburn MA, Lipman AG. Pain in society. In: Lipman AG, ed. Pain Management for Primary Care Clinicians. Bethesda, Md: American Society of Health-System Pharmacists; 2004: 1.
Woolf CJ. Pain: moving from symptom control toward mechanism-specific pharmacologic management. Ann Intern Med. 2004;140:441-451. Abstract
Merskey H, Bogduk N. Classification of chronic pain, 2nd ed. Seattle, Wash: IASP Press; 1994: 394.
Backonja MM. Defining neuropathic pain. Anesth Analg. 2003;97:785-790. Abstract
International Association for the Study of Pain. IASP Pain Terminology, available at http://www.iasp-pain.org/terms-p.html. Accessed April 13, 2006.
Bridges D, Thompson SWN, Rice ASC. Mechanisms of neuropathic pain. Br J Anaesth. 2001;87:12-26. Abstract
Yaksh TL. Calcium channels as therapeutic targets in neuropathic pain. J Pain. 2006;7:S13-S30. Abstract
Markman JD, Dworkin RH. Ion channel targets and treatment efficacy in neuropathic pain. J Pain. 2006;7:S38-S47. Abstract
Dworkin RH, Backonja M, Rowbotham MC, et al. Advances in neuropathic pain: diagnosis, mechanisms, and treatment recommendations. Arch Neurol. 2003;60:1524-1534. Abstract
O'Connor AB, Dworkin RH. Chronic neuropathic pain and advances in its treatment. Progress in Neuropathic Pain, Continuing Education Monograph. Sonora, Calif: American Academy of Pain Management; 2005.
Gilron I, Bailey JM, Tu D, et al. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med. 2005;352;1324-1334. Abstract
Beydoun A, Backonja MM. Mechanistic stratification of antineuralgic agents. J Pain Symptom Manage. 2003;25:S18-S30. Abstract
Hahn K, McPherson ML. Neuropathic pain. Program and abstracts of the American Pharmacists Association 2006 Annual Meeting; March 17-21, 2006; San Francisco, California.

« Last Edit: May 17, 2006, 04:42:25 pm by Kathy » Logged


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« Reply #1 on: November 24, 2006, 08:55:29 am »


Anesiva Starts Phase ~ Study of 1207 for Pain

Pain & Central Nervous System Week
 
2006 NOV 24  -- Anesiva, Inc., (ANSV) announced that it has commenced phase I clinical testing of product candidate 1207, a new topical local anesthetic for the potential treatment of numerous pain conditions, including neuropathic pain.

The study, designed to assess the safety of 1207, will enroll 24 adult healthy male volunteers in up to six dose-escalating cohorts in Australia. In addition to safety data, the randomized, double-blind, placebo-controlled study will measure sensory perceptions of touch and warmth following a single topical administration of 1207 compared with placebo.

"Preclinical data suggest that 1207 could offer rapid and deep-penetrating relief as a topical treatment for neuropathic pain, or potentially for surgical incision pain prior to dermatological surgery," said Daniel J. Gennevois, MD, vice president of medical affairs at Anesiva. "With 1207 entering the clinic, we now have three novel products in various stages of advanced development, each of which offers the promise to address significant unmet medical needs in the pain market."

1207 is a new chemical entity with novel anesthetic properties that provide pain relief by binding to the fast sodium channel on neurons responsible for transmitting pain signals from nerve endings to the brain. Specifically, 1207 binds to the fast sodium channel on both A nerve fibers responsible for transmitting immediate "adaptive pain" signals and C nerve fibers responsible for transmitting longer-term, dull, aching throbbing pain signals.

By interrupting the communication channel of both A fibers and C fibers, 1207 is designed to provide effective topical pain relief with a faster onset and longer duration of action than currently marketed pain products. In preclinical testing, topical administration of 1207 demonstrated a long duration of action and deep, rapid penetration. Other potential applications for 1207 include pre-procedural use in dermatological surgery and post-surgical incision pain.

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« Reply #2 on: November 26, 2006, 10:38:19 am »

Nerve pain

 
Nerve pain needn't be debilitating
 
 
Pain that arises from nerves -- neuropathic pain -- can be the most intense and debilitating pain that an individual experiences.

Pain from nerves often is associated with other diseases such as diabetes. In many cases, the underlying disease attacks nerve tissue and alters nerve function. These attacks then cause the nerve tissue itself to generate pain signals.

Many causes – and no identifiable cause
Some of the diseases most commonly associated with neuropathic pain are diabetes, shingles, AIDS, cancer and peripheral vascular disease. Nerve entrapments by tumors or a disk in the back also can cause nerve pain, as well as traumatic injury to nerves.

Some individuals suffer from nerve pain for which a cause is not identified. These patients have what is known as "idiopathic neuropathy. " Chronic regional pain syndrome is a type of neuropathic pain that can follow minor or serious injury to nerves.

One of the earliest descriptions of neuropathic pain came from Dr. Weir Mitchell, a Union army physician during the Civil War. Dr. Mitchell saw many traumatic nerve injury patients from wounds suffered in battle.

He wrote, "In our early experience of nerve wounds, we met with a small number of men who were suffering from a pain which they described as ‘burning,’ as ‘mustard red hot’ or as a ‘red hot file rasping the skin.’ Its intensity varies from the most trivial burning to a state of torture."

Dr. Mitchell’s observations about the type of pain that his patients experienced is as useful today as it was during the Civil War.

Varying symptoms and treatment
Symptoms of neuropathic pain include burning, sharp shooting pains, electric shock types of pain and intermittent high-intensity lighting-like pain. Many individuals have severe pain associated with light touch, temperature changes and contact with clothing or other objects.

This pain is far more severe than one would expect given the nature of the contact. Neuropathic pain often is difficult to diagnose because seldom is the nueropathic pain the patient’s only problem. This means that neuropathic pain can be missed as one of the aspects of an individual’s total pain complaint.

Treatment for neuropathic pain begins with establishing the diagnosis. Once that is done, a number of medications can offer help with this type of pain. However, anti-seizure drugs, tricyclic antidepressants, Valium-like drugs, anti-inflammatory drugs and narcotics all can be used to treat neuropathic pain.

Some injection therapies (nerve blocks) also can be done for some types of nerve pain. In general, medications offer the best choices for treatment.

Diabetic pain
Diabetic neuropathy is the most common type of neuropathic pain syndrome seen by physicians. High blood sugar levels attack the nerve tissue, causing pain to start in the hands and feet.

This pain follows what is commonly known as"stocking and glove” distribution. This means that the area affected would be covered by one’s socks or gloves. Treatment of diabetic neuropathy begins with gaining good control over blood sugar levels. Close monitoring and adjustment of diet and insulin doses can promote better blood sugar control and thereby reduce neuropathy pain.

Some patients can judge how they are doing with blood sugar control based on how much pain they have. However, some diabetics develop neuropathy pain in spite of good blood sugar control.

The first step in treating any kind of neuropathy pain is to see your physician for evaluation. If difficulty arises in treating pain, a referral to a pain specialist might be indicated.

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« Reply #3 on: December 04, 2006, 04:05:59 pm »

What causes neuropathic pain?
Pain is normally felt through nerve endings called nociceptors (no-si-sep-ters) which send messages from the site of the injury, such as a strained muscle, to the brain. If the nerves within the peripheral or central nervous system are damage in some way this can lead to incorrect nerve signals being sent to the brain which in turn results in continuous chronic pain.


The pain that is felt is real but the cause can often be difficult to discover. Patients with a wide range of medical conditions can develop neuropathic pain, these can include trauma caused by an accident or surgery, infection, vascular disease, cancer and metabolic conditions such as diabetes. Occasionally no identifiable cause is found which is incredibly frustrating for the individual experiencing the pain.

The primary goals of treatment for neuropathic pain are to reduce the pain as much as possible, balance the negative side effects of the treatment, and help patients manage any unresolved pain. Individuals with chronic pain may be able to attend a pain clinic for assessment, management and advice on living with chronic pain.
There are various treatments available for neuropathic pain and often it is a ‘trial and error’ process to find what is best suited, here is a brief outline of the most common ones:

Anti-convulsant (epilepsy) medication
Examples: Carbamazipine, Gabapentin, Pregabalin
Primarily used for the treatment of epilepsy, however, it is also stabilises irritable nerve membranes thus reducing pain. Being prescribed an anti-convulsant does not mean you have or are at risk of developing epilepsy.
Common side effects: feeling ‘spaced out’, dizziness and headaches

Tri-cyclic anti-depressants
Examples: Amitriptyline, Dothiepin, Clomipramine
Primarily used for depression however it has been found that this group of drugs also inhibits nerve pain. Being prescribed an anti-depressant does not mean that you have or are at risk of developing depression. It can take several weeks for this group of drugs to build up to an effective level in the body.
Common side effects: Sedation and dry mouth

Capsicum Cream
Derived from chilli peppers. The cream is absorbed through the skin to reduce levels of Substance P, the neuro-transmitter which is associated with inflammation and pain. Beneficial effects may be experienced with regular use (3-4 times a day).
Common side effects: Localised heat and redness.

Anti-spasmodics/muscle relaxants
Examples: Baclofen, Diazepam (also an anti-depressant)
Common side effects: drowsiness, confusion, dizziness and poor co-ordination

NSAID’s (non steroidal anti-inflammatory drugs)
Examples: Ibuprofen and Diclofenac (Voltarol)
Only has limited use for neuropathic pain, effects tend to be short term.
Common side effects: irritation of stomach

Trans Electrical Nerve Stimulation (TENS)
A machine which produces a mild electrical impulse. Electrodes from the machine are placed on the skin over the area of pain. It is believed that selective stimulation of certain nerve fibres could block signals carrying pain impulses to the brain. TENS can be self administered however it is advisable that individuals should be given a supervised trial prior to use. Common side effects: allergic reaction/skin irritaion to electrodes

Opioids
Examples: Morphine, Oxycodone, Fentanyl, Tramadol
Until recently neuropathic pain was thought to be resistant to opioids, however some individuals do find them beneficial.
Common side effects: feeling ‘spaced out’, constipation, drowsiness, nausea

Injections/nerve blocks
Examples: usually a combination of a local anaesthetic agent, opioids and steroids. Nerve blocks are not a permanent cure but can reduce the pain for several days or weeks before it returns to severity.
Side effects: infection, allergic reaction

Pain management programmes
Example: NHS Expert Patient Programme that provides opportunities for people who live with long-term chronic conditions, such as neuropathic pain, to help develop new skills to manage their condition better on a day-to-day basis.

Acupuncture
Acupuncture is a system of healing which involves the insertion of fine needles into specific points/energy channels on the body. It is believed that this stimulates the body’s own healing response and helps restore a natural balance. Acupuncture needles are very fine and when inserted the sensation is often described as a tingling or dull ache.

Other complimentary therapies
There are many other therapies that can be used in conjunction or as an alternative to conventional treatment. These include therapies such as reflexology, aromatherapy and homeopathy.

Bio feedback/relaxation
A technique based on the idea that you can learn to control and influence some of the things that your body does automatically. Most patients who benefit from biofeedback are trained to relax and modify their behaviour. It is believed that relaxation is a key component in biofeedback treatment.



Living with neuropathic pain
Pain is a very complex condition and each person is affected differently. It has many physical and psychological components and individuals can experience fatigue, anxiety, mood changes and depression.
As pain cannot be seen, it is hard to explain to someone exactly what it feels like and therefore it is hard for others to understand just how much it can affect every day life.

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« Reply #4 on: October 10, 2007, 08:47:12 am »

The Effect of Menthol on Cold Allodynia in Patients with Neuropathic Pain


ABSTRACT
 
Objective. Cutaneous application of menthol in healthy subjects induces cold allodynia via sensitization of cold-sensitive nociceptors. We investigated the effects of menthol on preexisting cold allodynia in patients to test whether the allodynia was exacerbated.

Design. In eight neuropathic pain patients (six of peripheral, two of central origin), 40% menthol was applied topically to an area of preexisting cold allodynia. Mirror-image skin areas and aged-matched healthy subjects served as controls in patients with unilateral and bilateral neuropathic pain, respectively. Prior to and after menthol, cold pain thresholds were measured using a thermotest device.

Results. Menthol induced significant cold allodynia in control areas. However, in neuropathic areas, results were more heterogeneous. Overall, preexisting cold allodynia was not aggravated by topical menthol and was attenuated in 6/8 patients.

Conclusions. These results suggest that, unlike in controls, menthol is not more hyperalgesic, but may be analgesic in some patients with peripheral and central neuropathic pain.

Gunnar Wasner, MD,**Prince of Wales Medical Research Institute, Division of Neurological Pain Research and Therapy, Department of Neurology, University of Schleswig-Holstein, Campus Kiel, GermanyUniversity of New South Wales, Sydney, New South Wales, Australia; Priv.-Doz. Dr. med. Gunnar Wasner, MD, Prince of Wales Medical Research Institute, Gate 1 Barker St, Randwick, Sydney, NSW 2031, Australia. Tel: 2-93991039; Fax: 2-93991034; E-mail: g.wasner@unsw.edu.au. Dennis Naleschinski,Division of Neurological Pain Research and Therapy, Department of Neurology, University of Schleswig-Holstein, Campus Kiel, Germany Andreas Binder, MD,Division of Neurological Pain Research and Therapy, Department of Neurology, University of Schleswig-Holstein, Campus Kiel, Germany Jörn Schattschneider, MD,Division of Neurological Pain Research and Therapy, Department of Neurology, University of Schleswig-Holstein, Campus Kiel, Germany Elspeth M. McLachlan, PhD, DSci,**Prince of Wales Medical Research Institute, University of New South Wales, Sydney, New South Wales, Australia; and Ralf Baron, MDDivision of Neurological Pain Research and Therapy, Department of Neurology, University of Schleswig-Holstein, Campus Kiel, Germany *Prince of Wales Medical Research Institute, University of New South Wales, Sydney, New South Wales, Australia; Division of Neurological Pain Research and Therapy, Department of Neurology, University of Schleswig-Holstein, Campus Kiel, Germany
Priv.-Doz. Dr. med. Gunnar Wasner, MD, Prince of Wales Medical Research Institute, Gate 1 Barker St, Randwick, Sydney, NSW 2031, Australia. Tel: 2-93991039; Fax: 2-93991034;
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« Reply #5 on: January 13, 2009, 02:02:56 pm »

Opioids provide relief from neuropathic pain

Jan. 13, 2009
The pain that is associated with injury to nerves, such as caused by the trauma of amputation, entrapment, and compression, is known as neuropathic pain. It can be extremely debilitating, and treatments show limited or no effectiveness. Nerve injury underlying neuropathic pain is associated with an inflammatory response, and immune cells are thought to be contributors to the pain. However, Halina Machelska and colleagues, at Freie Universität Berlin, Germany, have now shown that in a mouse model of neuropathic pain, a substantial proportion of the immune cells at the site of nerve injury produce chemicals known as opiods that markedly reduce the symptoms of neuropathic pain. The authors therefore suggest that selectively targeting opioid-containing immune cells at sites of nerve injury could provide natural pain relief and offer a novel approach for neuropathic pain.


SOURCE:
TITLE: Immune cell–derived opioids protect against neuropathic pain in mice

AUTHOR CONTACT:
Halina Machelska
Freie Universität Berlin, Medizinische Fakultät Charité-Universitätsmedizin Berlin, Berlin, Germany.
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« Reply #6 on: January 16, 2009, 02:14:22 pm »

TRIAL RESULTS

Neurotune Successfully Completes Phase 1 Trials with its Lead Compound NT-11624


January 16, 2009--Neurotune AG, a Swiss biopharmaceutical company, which has recently acquired two programs in neuropathic pain, announces the successful completion of Phase I for its lead compound NT-11624 developed for treatment of neuropathic and ostheoarthritic pain.

NT-11624, dimiracetam, is a selective small molecular NMDA-receptor antagonist, which acts on a new site of the receptor. The studies on 56 healthy volunteers performed in Switzerland have demonstrated excellent tolerability of the compound both by subjective reports and objective physical, instrumental and laboratory tests with favorable kinetics and no clinically relevant food effects on the molecule kinetics.

"We have reached an important step in the development of our Company" said Andreas J. Schulze PhD, Neurotune's CEO "as we are preparing for the submission of the regulatory approval of a phase II study in South Africa on pain caused by retroviral treatment induced peripheral neuropathy in HIV patients". "The data obtained" - added Ruggero G. Fariello MD, Neurotune's CMO - "are such to allow us to move confidently into clinical pathologies to explore efficacy of our product in a wide range of doses, giving us the confidence of an optimal tolerability profile within that range".

SOURCE: PRESS RELEASE
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« Reply #7 on: February 01, 2009, 09:40:04 am »

EpiCept: promising pain cream offers risky route to lucrative market

Feb.1,2009


Despite positive Phase IIb results for NP-1 in post herpetic neuralgia, EpiCept faces the challenge of gaining a broad peripheral neuropathy label as well as dispelling concerns over safety issues with the amitriptyline/ketamine combination. Assuming the company is successful, then NP-1 could become a leading brand in the growing topical neuropathic pain drug market.


EpiCept announces positive results from Phase IIb trial for NP-1 in post herpetic neuralgia.

The Phase IIb randomized, double blind, placebo controlled, non-inferiority four-week trial of NP-1 (amitriptyline plus ketamine topical cream) in 360 patients with post-herpetic neuralgia (PHN), met its primary endpoint of superior pain relief over placebo (p=0.024). An additional primary endpoint, to demonstrate that NP-1 was not inferior to gabapentin (a popular neuropathic pain treatment), in reducing pain, was also met, while at the same time demonstrating a favorable safety profile.

This is an encouraging result as gabapentin has a relatively benign side effect profile, although critics of NP-1 may still question the drug based on potential adverse events. In their oral forms, the combination's constituents, amitriptyline (an old antidepressant used to treat neuropathic pain), and ketamine (a stigmatized drug of abuse) are well known to cause undesirable central side effects.

EpiCept is pursuing a high-risk, high-reward strategy by seeking the broad peripheral neuropathy indication in order to gain marketing access to the wider patient base, and is thus challenging the current FDA stance on neuropathic pain labeling. Current US-approved neuropathic pain drugs are restricted to a narrow label for specific pain types, although they are used extensively off-label for others.

EpiCept's PHN trial is one of three studying the effects of NP-1 on indications within peripheral neuropathy. In February 2008, less encouraging results of a Phase II study for diabetic neuropathic pain were announced, which showed that NP-1 did not meet its primary endpoint; but did show a trend towards long-term pain relief. A third trial in chemotherapy-induced peripheral neuropathy is currently ongoing.

With a value of around $2.9 billion in 2008 across the seven major markets, Datamonitor forecasts the neuropathic pain market to grow to over $6 billion by 2017. As demonstrated by the success of Endo's Lidoderm (lidocaine patch 5%), the neuropathic pain market offers substantial opportunities for topical agents. Other key topicals in development include NeurogesX's Transacin (capsaicin) and King/Durect's Eladur (bupivacaine). Datamonitor forecasts NP-1 to capture almost 40% of the topical neuropathic pain drug market by 2017, with peak sales of $145m. However, sales could be even greater if these positive results are repeated in Phase III studies and a suitable licensing partner is found to market NP-1.
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« Reply #8 on: February 01, 2009, 09:41:52 am »

High-Concentration Capsaicin Patch Provides Pain Relief in Diabetic Neuropathy, HIV Polyneuropathy, and Postherpetic Neuralgia: Presented at AAPM

A high-concentration capsaicin patch, NGX-4010, is effective in treating painful diabetic neuropathy (PDN), painful HIV-distal sensory polyneuropathy (HIV-DSP), and postherpetic neuralgia (PHN), according to results from 2 open-label, multicentre studies.

      The studies were presented here on January 29 at the American Academy of Pain Medicine (AAPM) 25th Annual Meeting.

      In the first study, Lynn Webster, MD, Lifetree Clinical Research & Pain Clinic, Salt Lake City, Utah, and colleagues enrolled 91 patients with PDN with moderate to severe pain in both feet.

      Patients received pretreatment with a topical anaesthetic followed by a single NGX-4010 treatment applied for 60 or 90 minutes. Outcomes were compared with baseline measures.

      Overall, patients achieved a mean decrease of 32% in pain scores from baseline during weeks 2 to 12, while 48% of patients demonstrated a response, as indicated by at least a 30% decline in pain scores from baseline. The most common adverse event was local application-site reaction.

      The second study involved a safety analysis of repeated applications of NGX-4010 over 1 year in 106 patients with HIV-DSP or PHN.

      Topical administration of 4% lidocaine was followed by a single 60-minute (PHN and HIV-DSP) or 90-minute (HIV-DSP) treatment with NGX-4010. Patients were allowed to receive up to 3 additional applications spaced at least 3 months apart.

      A total of 293 NGX-4010 treatments were administered. Adverse events were generally transient and included redness at the application site in up to 96% of applications, pain in up to 73% of applications, and oedema in up to 11% of applications.

      The incidence of adverse events did not appear to be associated with the number of applications or improvement in pain outcomes. Transient changes in blood pressure were noted.

      "Adverse events were as [had been] expected, and we were encouraged that we did not see any sensory function changes or systemic adverse events with our treatment over 48 weeks, even with repeated applications," said the study's lead author, David M. Simpson, MD, Mount Sinai School of Medicine, New York, New York.

      The transient receptor potential vanilloid receptor (TRPV1) is expressed in nociceptive fibres that perceive pain, Dr. Simpson said in an interview. Capsaicin is a TRPV1 agonist that causes desensitisation of TRPV1 channels with an analgesic effect.

      NGX-4010 contains a form of synthetic capsaicin, known as trans-capsaicin, at an 8% concentration that is delivered directly to the pain site. According to the manufacturers, findings from clinical trials suggest that a single topical application of NGX-4010 may provide 3 months of pain relief with minimal potential for adverse effects or drug-drug interactions.

      The new drug application for NGX-4010 was accepted by the US Food and Drug Administration in December 2008, and approval for marketing is expected in late 2009, according to the drug's manufacturer, NeurogesX Inc., which provided funding for these studies.

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« Reply #9 on: February 03, 2009, 12:22:56 pm »

Mint pain killer could save the NHS millions

February 3,2009

RESEARCH being carried out at Edinburgh University has suggested that a pain-killing cream containing mint could save the NHS millions of pounds.
Tens of thousands of people across Scotland are believed to suffer from neuropathic pain which is caused by damage to the nerve endings.

However early findings from the Capital's researchers suggest that a cream containing a small amount of mint could relieve this pain more effectively than many drugs currently available.

The cream could cost just £10 a month – compared to several hundred pounds spent per month for current medications.

The researchers hope to recruit around 40 patients to take part in the new study, particularly those undergoing cancer treatment which can cause neuropathic pain.

It is hoped that the cream, if successful, could be widely available within the next two years.

Source: Edinburgh Evening News
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« Reply #10 on: February 17, 2009, 05:22:20 pm »

Feb 16, 2009
WEX Reports Third Quarter Results
[/b]

WEX Pharmaceuticals Inc. ("WEX" or the "Company") (TSX:WXI) reported events and financial results for the three-month and nine-month periods ended December 31, 2008. All amounts, unless specified otherwise, are in Canadian dollars.

ஐﻬ Third Quarter and Subsequent Events

- During the quarter, we continued to focus our efforts and resources on our Canadian pivotal trials for TTX in cancer-related pain, TEC-006 and TEC-006OL, signing up more clinical sites and enrolling more patients. As of February 16, 2009, the Company has eight active sites and has enrolled 27 patients in the TEC-006 trial.

- We have developed a plan for a proof-of-concept trial of TTX in chemotherapy-induced neuropathic pain (TEC-007). We had a successful meeting with Health Canada in December and, subject to assessment of feasibility and receiving regulatory clearance, we anticipate starting the trial in the second calendar quarter of 2009.

- In November, we appointed Mr. James Oon as Director of Operations for our Asia subsidiaries. A chemical engineer by training, Mr. Oon holds both MSc and MBA degrees, and has over 20 years experience in the pharmaceutical industry in Europe and Asia. His experience will prove invaluable as we further develop and implement our manufacturing strategies.

ஐﻬ Financial Results - Unaudited

For the three months ended December 31, 2008, the Company recorded a loss of $1.905 million ($0.03 per share) compared to a loss of $523,000 ($0.01 per share) in the same period in the preceding year. The increase in loss of $1.382 million for the three months ended December 31, 2008, when compared to the same period in the preceding year, is largely attributable to the increase in research and development activities for the TEC-006 and TEC-006OL clinical trials.

For the nine months ended December 31, 2008, the Company recorded a loss of $4.890 million ($0.08 per share) compared to a loss of $2.041 million ($0.04 per share) in the same period in the preceding year. The increase in loss of $2.849 million for the nine months ended December 31, 2008, when compared to the same period in the preceding year, is attributable to the increase in research and development activities for the TEC-006 and TEC-006OL clinical trials in the current year and gain in foreign exchange and also settlement gains in the US dollar denominated convertible debentures series 5.5% in the preceding year.

As at December 31, 2008, the Company had cash and short-term investments of $6.63 million compared to $3.20 million at December 31, 2007.


About WEX Pharmaceuticals Inc.

WEX Pharmaceuticals Inc. is dedicated to the discovery, development, manufacture and commercialization of innovative drug products to treat pain. The Company's principal business strategy is to derive drugs from naturally occurring toxins and develop proprietary products for the global market.


SOURCE: Press Release
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« Reply #11 on: March 14, 2009, 11:20:54 am »

Targacept halts development of drug targeting neuropathic pain

Mar. 12, 2009

 Biopharmaceutical firm Targacept said Wednesday it would stop development of a potential drug it was researching in partnership with GlaxoSmithKline.

The compound called TC-6499, was intended to treat neuropathic pain. Phase I testing showed that the drug results “do not project a therapeutic margin sufficient to support further development.”

In December, Targacept (Nasdaq: TRGT) said it would not pursue further development of a potential treatment for schizophrenia after the drug failed to produce “statistical significance” in a clinical trial.

Targacept and its partner AstraZeneca, which paid for the trial and rights to the compound known as AZD3480, said the compound did not meet trial targets for improvement in cognitive functions.

GSK and Targacept formed a drug development alliance in July of 2007 that focuses on neuronal nicotinic receptors (NNRs). Five targets for the program include pain, smoking cessation, addiction, obesity and Parkinson’s disease.

Targacept is focused on research into NNRs. They are a class of proteins in the nervous system that control levels of chemical messengers such as dopamine. According to Targacept, nicotine has been linked to over-stimulation of dopamine in brain regions that are involved in feelings of reward and pleasure.

“While we are disappointed not to be moving TC-6499 forward, we have learned a great deal about the NNR targets involved in perception of pain,” said J. Donald deBethizy, Targacept’s chief executive officer. “Importantly, our alliance with GlaxoSmithKline continues to make progress as we remain focused on advancing programs in smoking cessation, obesity, Parkinson’s disease, addiction and pain. We are fortunate to have a pipeline of NNR therapeutics representing multiple opportunities for future success.”


SOURCE:PR RELEASE
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« Reply #12 on: May 12, 2009, 08:16:07 am »

SMC approves Lyrica (pregabalin) for peripheral neuropathic pain

Monday 11th May 2009

 Pfizer Ltd is pleased that the Scottish Medicines Consortium (SMC) has recommended Lyrica (pregabalin) for use within NHS Scotland for the treatment of peripheral neuropathic pain in patients who have not achieved adequate pain relief from, or have not tolerated, conventional first and second line treatments.

Dr Berkeley Philips, Medical Director, Pfizer Limited said: “Peripheral neuropathic pain affects between 80,000 and 160,000 people in Scotland, and is associated with significant co-morbidities, reduced quality of life and socio-economic burden.

In clinical practice, some patients still fail to achieve adequate pain relief despite trying multiple pain medications. This decision represents a positive step for patients and physicians in Scotland and provides a valuable, additional treatment option”.

The Pfizer submission to the SMC focused on the use of pregabalin in patients with peripheral neuropathic pain who were refractory to earlier treatments. As part of the submission evidence from six non-randomised studies (including studies in the UK and Scotland) were presented to show an efficacy benefit of pregabalin in 242 treatment-refractory patients, comparable to the efficacy demonstrated in pregabalin clinical trials. This evidence included patients with a variety of peripheral neuropathic pain syndromes, who have previously tried and failed on multiple pain treatments, including tricyclic antidepressants and gabapentin.

In addition, evidence was provided that demonstrated pregabalin as an effective treatment for peripheral neuropathic pain, compared to placebo or usual care, in 22 RCTs and sustained efficacy and tolerability in 16 open-label studies up to two years in duration.

SOURCE:Pfizer
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« Reply #13 on: November 17, 2009, 02:44:06 pm »

FDA Approves Capsaicin 8% Patch for Treatment of Postherpetic Neuralgia


 November 17, 2009

 The US Food and Drug Administration (FDA) has approved capsaicin (Qutenza) 8% patch for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles. This is the first approved product containing prescription-strength capsaicin, the substance in chili peppers that gives them their heat sensation. The patch delivers a synthetic form of capsaicin, providing up to 12 weeks of reduced pain following a single 1-hour application. "PHN can be an excruciatingly painful condition that can affect many aspects of a patient's quality of life. Despite a variety of medications for pain, undesirable side effects often limit their use and, therefore, the treatment of PHN continues to represent a significant unmet need," said Lynn Webster, MD, Lifetree Clinical Research, Salt Lake City, Utah. "[The capsaicin 8% patch] may provide a unique treatment option that works at the site of the pain and may be useful as a treatment option in combination with existing therapies." The treatment works by targeting certain pain nerves in the area of skin where pain is being experienced. The patch is applied by a physician or a healthcare professional. Clinical studies have shown that PHN pain can be reduced for up to 12 weeks following a single 1-hour treatment. Up to 4 patches may be used and patches may be cut to conform to the size and shape of the painful area. Capsaicin 8% patch is a locally-acting, non-narcotic medication that is unlikely to cause drowsiness or have drug-drug interactions. Treatment may be repeated every 3 or more months as warranted by the return of pain. In clinical trials, the most common adverse reactions were application site redness, pain, itching, and papules. The majority of these reactions were transient and self limited. Among treated patients, 1% discontinued prematurely due to an adverse event. Serious adverse reactions included application site pain and increased blood pressure. Increases in blood pressure occurred during or shortly after exposure to the treatment. The changes were on average <10 mm Hg; although, some patients had greater increases and these changes lasted for approximately 2 hours after patch removal. The capsaicin 8% patch also has been approved in the European Union.


SOURCE: NeurogesX, Inc.


 
 

 
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