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« Reply #60 on: January 16, 2009, 01:43:20 pm »

Savella Approved for Fibromyalgia
Expected in pharmacies by March


 Jan. 16, 2009~ Savella (milnacipran hydrochloride) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia,ஐﻬ  a chronic condition characterized by restricted movement and widespread pain, makers Forest Labs and Cypress

The safety and effectiveness of the drug, a selective serotonin and norepinephrine dual reuptake inhibitor, were established in clinical trials involving 2,084 patients. In a news release, the drug's makers said it's not known exactly how Savella ஐﻬ improves symptoms of fibromyalgia, which some scientists believe is related to abnormalities in certain brain neurotransmitters.

As many as 6 million Americans haveஐﻬ  fibromyalgia, making it the second-most common condition diagnosed in rheumatology clinics behind osteoarthritis, the companies said. There is no cure.

Savella is expected in pharmacies by March. Common side effects reported during clinical testing included constipation, hot flushesஐﻬ , vomiting, heart palpitations, dry mouth, and a rise in blood pressure.

SOURCE:ஐﻬ  The FDA has more information about this drug.

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
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« Reply #61 on: January 31, 2009, 10:04:09 pm »

Milnacipran Validated for Treatment of Fibromyalgia: Presented at AAPM
By Emma Hitt, PhD

 January 30, 2009

Use of milnacipran 200 mg/day for up to 12 weeks appears to be safe and effective in a trial of patients with fibromyalgia, suggests a study presented here at the American Academy of Pain Medicine (AAPM) 25th Annual Meeting.

      Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor. Milnacipran was approved for use in fibromyalgia in the United States in January 2009 for the treatment of fibromyalgia, making it the third medication approved for this purpose in the United States. Milnacipran is not yet approved in Europe.

      This current study, led by Mike Gendreau, MD, Cypress Bioscience, Inc., San Diego, California, investigated the efficacy and safety of milnacipran 200 mg, the highest dose approved, in treating fibromyalgia in a European population. Dr. Gendreau presented the results on January 29.

      A total of 884 patients from 83 sites across Europe with fibromyalgia were randomised to receive a 16-week regimen of milnacipran for 200 mg/day or placebo.

      At 16 weeks, compared with placebo, milnacipran significantly increased the primary efficacy endpoint of a composite score of pain and fibromyalgia scores (P = .0003). The Fibromyalgia Impact Questionnaire (FIQ) total score was also significantly improved (P = .015) as were other measures of pain, physical function, fatigue, and sleep quality.

      The most common adverse events associated with milnacipran were mild to moderate in severity and included nausea (26.0% vs 11.2%), hyperhidrosis (23.7% vs 2.9%), and headache (20.9% vs 14.8%).

      Funding for the study was provided by Pierre Fabry, Inc., which originally developed and sells milnacipran outside of the United States.

SOURCE: PRESS RELEASE
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« Reply #62 on: February 03, 2009, 12:18:05 pm »

Duloxetine Has Good Long-Term Safety and Efficacy in Patients With Fibromyalgia: Presented at AAPM

February 3, 2009

 Duloxetine maintains efficacy and safety outcomes for at least 1 year, according to the findings of 6-month extensions of 2 randomised, double-blind, placebo-controlled, clinical trials patients with fibromyalgia presented here at the American Academy of Pain Medicine (AAPM) 25th Annual Meeting.

      Madelaine Wohlreich, MD, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, and colleagues conducted 2 randomised trials of duloxetine in patients with fibromyalgia. The study was presented on January 30.

      The first study included 278 patients who received duloxetine 120 mg/day after they completed 28 weeks of placebo or duloxetine 60 or 120 mg/day. The second study included 204 patients switched to duloxetine titrated to 60 mg/day after 27 weeks of placebo, and patients that previously received duloxetine and continued to 60 or 120 mg/day.

      In the 2 studies, 56.1% and 68.6% of patients, respectively, completed the 6-month extension phase for a total of 1 year of treatment.

      Most common treatment-emergent adverse events were nausea and dry mouth (20% and 16%, respectively), and occurred most often in patients titrated from placebo to duloxetine. No changes in blood pressure were observed. However, the researchers noted that "significant within-group mean increases in pulse rate occurred in patients titrating from placebo to duloxetine in both studies."

      Patients in both studies receiving switched from placebo to duloxetine showed significant improvement on the Patient Global Impressions-Improvement, the 36-item Short Form questionnaire, and most other efficacy outcomes.

      "These findings substantiate a positive risk/benefit profile for duloxetine in treatment of fibromyalgia, with efficacy maintained for up to 1 year," the authors concluded.

      "Duloxetine is an important treatment option that has been proven to reduce pain and improve function in people living with fibromyalgia," Dr. Wohlreich said in an interview. "By pooling placebo-controlled studies of duloxetine in fibromyalgia, power is added to address questions that the smaller individual studies could not adequately answer," she said.

      Another study presented at the same meeting showed that duloxetine was equally effective in treating fibromyalgia pain and other symptoms in patients with or without major depressive disorder.


      Funding for the study was provided by Eli Lilly and Company.

      [Presentation titles: Long-Term Safety, Tolerability, and Effectiveness of Duloxetine in the Treatment of Fibromyalgia. Abstract 204. Comparisons of the Efficacy and Safety of Duloxetine for the Treatment of Fibromyalgia in Patients With vs Without Major Depressive Disorder (MDD). Abstract 205]
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« Reply #63 on: February 11, 2009, 03:44:44 pm »

Drug firms under scrutiny for fibromyalgia campaigns
Drugmakers Eli Lilly and Co. and Pfizer are under scrutiny for spending millions of dollars raising awareness of fibromyalgia, even as physicians debate whether it is a distinct disease. Both companies have FDA-approved drugs for fibromyalgia, and an Associated Press analysis showed they donated more than $6 million in grants to nonprofit groups in 2008 for medical conferences and educational campaigns.

SOURCE: Washington Post, The (02/08)
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« Reply #64 on: February 11, 2009, 07:49:44 pm »

Quote
hello
my doctor was going to put me on lyrica but medicare wouldn't pay for it. i had been on neurotin but it doesn't mix well with topomax. Now I can get lyrica paid for but after reading the side effects one of the big things is tiredness and I need something to help that lol not make it worse. I am so glad that fibro is now being reconized as an illness. After so long of doctors saying it is in your head.
hugs
sue
Sue,
I'm sorry, I just now saw this. Sorry for being late in answering. But just about any meds for Fibro is going to have sleepy side effects, unless you take just plain old Tyelnol or Motrin (Ibuprophen<sp>)
I can't deal with the sleepiness and drunken state Nueronton puts me in mixed with my seizure meds and everything else I take.
Like you I don't want to sleep or be tired all the time, I have too much to do during the day.
I hope your Dr. finds you a good combo of meds that helps your pain levels as well as no problem side effects. It's hard to find a good med that doesn't have some side effect that messes with you..
Have you tried acupunchure <sp>?

Good luck and keep us posted!
Kathy

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« Reply #65 on: February 18, 2009, 02:23:56 pm »

Fibromyalgia Pain Linked To Central Nervous System Dysfunction

 Feb. 18, 2009~  Widespread body pain in fibromyalgia patients is associated with specific brain metabolite abnormalities, according to research in The Journal of Pain.

Scientists at Louisiana State University examined 16 fibromyalgia patients to assess the role in fibromyalgia pain played by metabolite abnormalities in the hippocampal region of the brain. The hippocampus is sensitive to the effects of stress exposure and can be affected in a variety of disorders, like fibromyalgia, which are associated with stressful experiences. Fibromyalgia is considered a stress-related disorder because of the frequent onset and exacerbation of pain symptoms. Brain imaging studies have shown there are central nervous system disturbances that occur in response to pain stimulation.

The researchers sought to explore the role of the hippocampus region in fibromyalgia pain, especially in pain perception, cognition and modulation of the central stress response.

From the analysis of subjects' brain scans, they found that exposure to chronic stress produces an increase hippocampal excitability that may play a role in the exaggerated sense of pain or hyperalgesia commonly experienced by fibromyalgia patients. Therefore, brain metabolite abnormalities in premenopausal fibromyalgia patients can disrupt the hippocampus region and inhibit brain activity required for modulating stress responses.

Journal reference:

   1. P. Wood, C. Ledbetter, M. Glabus, L. Broadwell, J. Patterson 2nd. Hippocampal Metabolite Abnormalities in Fibromyalgia: Correlation With Clinical Features. The Journal of Pain, 2008; DOI: 10.1016/j.jpain.2008.07.003

Adapted from materials provided by American Pain Society.


SOURCE:ScienceDaily
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« Reply #66 on: February 21, 2009, 11:19:25 am »

UCB announces top-line outcomes for proof-of-concept studies

Lacosamide in migraine prophylaxis and rotigotine in fibromyalgia syndrome did not achieve statistical significance for their primary endpoints

 UCB announced today top-line results from two proof-of-concept Phase IIa clinical trials to assess the efficacy and safety of lacosamide in migraine prophylaxis, and the efficacy and safety of rotigotine in fibromyalgia syndrome. These trials were designed to determine whether there is justification for further clinical development of lacosamide and rotigotine in these indications. The respective studies did not achieve statistical significance for their primary endpoints. UCB will evaluate development plans once full analyses are available.


ஐﻬ Phase IIa study: lacosamide in migraine prophylaxis

The multicentre, randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy of lacosamide (100 mg/day and 300 mg/day) compared to placebo in reducing the frequency of migraine. The primary efficacy variable was the mean reduction of migraine rates during the 14-week maintenance period compared to the average frequency during the 4-week baseline period. Patients in this trial (218) had a history of episodic migraine with or without aura for at least 1 year and a well-documented three month retrospective history of migraines prior to enrolment. The trial did not meet its primary endpoint. However, a reduction in headache frequency was consistently observed in all treatment groups.

ஐﻬ Phase IIa study: rotigotine in fibromyalgia syndrome

The multicentre, randomized, double-blind, placebo-controlled trial was designed to investigate the efficacy and safety of rotigotine (4 mg/24 h and 8 mg/24 h) compared to placebo in adult patients (240) with signs and symptoms of fibromyalgia syndrome. The primary efficacy variable was the reduction in pain for patients taking rotigotine as measured by the average Likert pain score at baseline to the last two weeks of the 13 week treatment period. The study results did not achieve statistical significance for its primary endpoint. Only primary efficacy and safety data have been reviewed at this time.

ஐﻬ About UCB

UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 10 000 people in over 40 countries, UCB aims to achieve revenues of at least EUR3.3 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).

ஐﻬ About Migraine

Migraine is a common, disabling primary headache disorder. It typically affects one side of the head and may be pulsating, of moderate to severe intensity, and aggravated by routine activity. Migraine headache can last up to two to three days and is commonly accompanied by nausea and vomiting, and/or intolerance to normal levels of light and sound. Migraine is two to three times more common in women than men.

ஐﻬ About Fibromyalgia

Fibromyalgia is an idiopathic, chronic, pain syndrome defined by widespread musculoskeletal pain and generalized tender points. Other common symptoms include sleep disturbances, fatigue, headache, morning stiffness and anxiety. Fibromyalgia is usually considered a disorder of women aged 20 to 50 years; however, it has also been observed in men, children, adolescents and older persons. Fibromyalgia is more common in relatives of people with fibromyalgia, suggesting the contribution of genetic factors.


For the pdf version of this press release, please click on the link below:

http://hugin.info/133973/R/1292262/292293.pdf

SOURCE: Press Release Feb. 21, 2009
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« Reply #67 on: March 01, 2009, 02:28:57 pm »

   

Joint replacement patients with fibromyalgia show high levels of dissatisfaction postoperatively

When considering a patient with fibromyalgia for total joint replacement, surgeons should be aware that, in a small study, these patients showed high levels of dissatisfaction postoperatively. “These are patients who basically have a very low threshold for pain. They’re hypersensitized and they hurt at all times,” Javad Parvizi, MD, FRCS, said during the American Academy of Orthopaedic Surgeons 76th Annual Meeting, here. “Unfortunately, these patients are not great candidates for joint arthroplasty based on this study.”

Fibromyalgia, he explained, is diagnosed as pain at rest associated with central sensitization. In general, patients with a high preoperative pain have less favorable outcomes in terms of pain relief..

He showed data from his small prospective study looking at 64 fibromyalgia patients who underwent total knee arthroplasty at the Rothman Institute in Philadelphia between 2000 and 2007. These patients were matched in a two-to-oneratio and underwent SF-36 and Likert Scale testing with a maximum of 400 points.


“The finding was that fibromyalgia patients were, first, less satisfied with the surgery as measured by Likert’s scale and, unfortunately, they had lower mental and physical SF-36 scores. The dissatisfaction [rate] was much higher among fibromayalgia patients than others,” Parvizi said.

He also showed that 35% of fibromyalgia patients were dissatisfied with their procedures, as compared to 9% of their matched controls.

“This suggests that patients with fibromyalgia are great candidates for preoperative therapy and counseling,” Parvizi said. ”It’s better if you have a patient with fibromyalgia who’s under control and can be treated first before you deal with their degenerative joint diseases.”

Reference:

    * Parvizi J. Choosing the right patient. Part of a symposium on Early Failures after total knee arthroplasty: Strategies for prevention. Presented at the American Academy of Orthopaedic Surgeons 76th Annual Meeting. Feb. 25-28, 2009. Las Vegas. [/b]
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« Reply #68 on: March 02, 2009, 07:25:36 pm »

Fibromyalgia, myofascial pain syndrome not the same
March 02,2009

The myofascial tissue is a connective tissue which surrounds muscle sheaths, ligaments, joint capsules, nerve sheath and other tissues. The myofascial acts like a tent, covering and protecting other body parts. In the normal healthy state, the fascia is relaxed and wavy in configuration. It has the ability to stretch and move without restriction. But, injuries, stress, inflammation, trauma, and poor posture can cause restriction to fascia and develop trigger points and myofascial pain in the affected muscles.

Myofascial pain syndrome is a dull, aching pain in areas of muscle, often in the buttocks, back, neck, and shoulders, and is most frequently the cause of neck and back pain. It often is associated with tender, hard areas called trigger points. When pressed, these trigger points are painful, and the pain can spread away from them. Mechanical stresses can perpetuate trigger points in most patients with persistent myofascial pain syndrome. The most common source of such physical stress is skeletal asymmetry, poor posture, repetitive overstrain of muscles, or prolonged immobility.

Fibromyalgia (FMS) is known to be a central sensitivity syndrome. It is mainly caused by imbalance of neurotransmitters. Pain is the main symptom of FMS. It generally occurs throughout the body, although it may start in one region, such as the neck, back, or shoulders, and may spread over a period of time. Its intensity varies from day-to-day and it can change locations. Patients with FMS, similar to myofascial pain syndrome, have multiple tender points in the neck, back, elbows and knees.

Myofascial pain syndrome is very common in fibromyalgia sufferers. But trigger points are not part of FMS. Trigger points from myofascial pain can be effectively treated with trigger point injection, massage and physical therapy. Treatment of both conditions is similar but not the same. Therefore, it is very important to differentiate both conditions and identify local myofascial pain in patients with FMS.

Fatigue is another major symptom of FMS. Sometimes, the fatigue is a greater problem than the pain. Sleep disturbances are common with FMS. These include trouble falling asleep, frequent awakenings during the night or tossing and turning all night. Furthermore, people with FMS frequently experience headaches, irritable bowel syndrome, irritable urinary syndrome or even cognitive disturbance.

Depression often goes hand in hand with fibromyalgia. Causes may include frustration of having chronic pain, not being able to cope with simple daily chores, and the feeling of isolation and disbelief from others who do not understand FMS. FMS involves imbalance of multiple neurotransmitters and is not just a psychological disorder. Depression alone will not cause FMS. The prognosis of combined depression and FMS is poor compared to that for individuals with FMS alone.

SOURCE:By DR. YONG H. TSAI of Florida
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« Reply #69 on: April 17, 2009, 07:50:24 pm »

Heroin Addiction Drug May Relieve Symptoms of Fibromyalgia
A pilot study on an experimental treatment yields promising results


A drug commonly used to treat heroin addiction appears to ease the symptoms of fibromyalgia, a poorly understood but potentially debilitating condition that affects up to 12 million people in the U.S. (4 percent of the population), a small pilot study has found.

"We have a medication that seems to have low side effects and seems to reduce pain and fatigue [in fibromyalgia patients]," says Jarred Younger, a pain researcher at Stanford University School of Medicine and co-author of the study appearing today in Pain Medicine. "I think this is a potential treatment to add to the doctor's arsenal," he adds, noting that longer studies involving more patients are needed to confirm the results.

Fibromyalgia, a mysterious ailment whose symptoms include chronic widespread muscle pain, fatigue, sleep problems, anxiety and depression, often appears between the ages of 34 and 53 and is more common in women (affecting 5 percent of women and 1.6 percent of men in the U.S.), the researchers report. The U.S. Food and Drug Administration (FDA) has approved three drugs for treating fibromyalgia, but many patients don't respond to them, Younger says.

For 14 weeks, Younger and his colleague Sean Mackey, chief of the pain management division at Stanford, monitored the symptoms of 10 women ages 22 to 55 with fibromyalgia before, during and after they took small doses (4.5 milligrams per day) of naltrexone, a drug that for about three decades has been used to wean addicts off of heroin and other street drugs. (Naltrexone works by latching onto nerve cell receptors where heroin and other opioid drugs would dock, thus blocking their ability to act on the cells and induce a feeling of being high.) Using handheld computers, the women reported the severity of their daily symptoms on a scale of one to 100 (100 being the most severe). Every two weeks, they visited the researchers who downloaded the data entered in the computers and ran tests to measure the women's pain thresholds for pressure, heat and cold applied to the skin.

Their findings: the severity of pain and fatigue fell by 30 percent during the weeks the women were taking naltrexone compared with those in which they were taking a placebo. Two of the women said the drug gave them vivid dreams and one said she had nausea and insomnia the first few nights that she took the pills, but otherwise no side effects were reported.

Younger, who suspects fibromyalgia is an autoimmune disorder (in which the body's immune system attacks healthy tissue), speculates that naltrexone is alleviating fibromyalgia symptoms not by blocking nerve cell receptors but by dampening the activity of microglia—immune cells in the brain and spinal cord that produce pro-inflammatory cytokines, which excite nerve cells responsible for creating the sensation of pain.

"These results are promising," says Dan Clauw, an anesthesiologist at the University of Michigan at Ann Arbor's Chronic Pain & Fatigue Research Center who was not involved with the study. But Clauw is not convinced that naltrexone works by suppressing immune cells; he thinks low doses of the drug might stimulate nerve cells to release pain-alleviating endorphins.

Regardless of how the drug works, the scientists agree that more research is needed to confirm these preliminary findings. The Stanford team is already about two thirds of the way through a 24-week follow-up study involving 40 patients. And although Younger hasn't started analyzing the data, he says, "The participants seem happy…I think it looks good."
SOURCE: Google
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« Reply #70 on: July 02, 2010, 04:56:32 pm »

Chelsea Therapeutics Reports Positive Interim Analysis of Phase II Trial of Droxidopa in Fibromyalgia

 July 1, 2010 (GLOBE NEWSWIRE) --

-- Independent Data Monitoring Committee Sees Meaningful Efficacy in Multiple Treatment Arms -- Trial Focusing on Novel Droxidopa/Carbidopa Combination Therapy -- No Significant Adverse Events or Safety Concerns Observed in Any Treatment Arm

 

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.

The purpose of this scheduled DMC meeting was to review the efficacy of each dose group and determine if the efficacy data supported dropping underperforming arms in order to increase the power in those arms most likely to demonstrate a clinically relevant therapeutic benefit. Following their assessment of each of the 12 arms using the study's primary endpoint, a reduction in pain as measured by the Short Form McGill Pain Questionnaire, the DMC recommended that 7 of the 12 arms of the trial be continued to completion. This recommendation was based solely on their efficacy analysis, as there were no observed safety concerns associated with any arm of the study. As a result of this recommendation, the study will now focus primarily on multiple doses of droxidopa in combination with 50mg carbidopa.

"The DMC's recommendation aligns with our assumption going into the trial that by pairing droxidopa with carbidopa to limit peripheral metabolism of droxidopa, we should be able to drive efficacy of droxidopa in the treatment of fibromyalgia," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "Following the interim analysis conducted by the DMC and subsequent recommendations, we can now, as hoped, allocate our full study resources to those treatment groups most likely to demonstrate therapeutic benefit and their associated control and placebo arms."

The Phase II trial, is a multi-centre, randomized, double-blind, placebo-controlled, dose response, factorial study that initially included 12 parallel groups evaluating droxidopa monotherapy, carbidopa monotherapy, droxidopa/carbidopa combination therapy or placebo. Accordingly, patients were randomized into each of 12 groups to receive: 200mg, 400mg or 600 mg of droxidopa TID; 25mg or 50mg carbidopa TID; 200/25mg, 400/25mg or 600/25mg droxidopa/carbidopa TID; 200/50mg, 400/50mg or 600/50mg droxidopa/carbidopa TID; or placebo over a 9-week treatment period.

Based on the DMC recommendation, the trial will be optimized to continue enrollment in the following seven arms: placebo; 50mg carbidopa TID, 600mg droxidopa TID; 400/25mg, 200/50mg, 400/50mg or 600/50mg droxidopa/carbidopa TID. The primary endpoint is the average reduction in pain as measured by the Short Form McGill Pain Questionnaire. Secondary outcomes of the study include Fibromyalgia Index Questionnaire (FIQ), Patient Global Impression of Change (PGI-C), Multidimensional Fatigue Inventory (MFI), and Hamilton Anxiety Depression survey (HAM-A).

Chelsea currently estimates top-line data from the study to be reported by year-end 2011.
About Droxidopa and Fibromyalgia

Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and, as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels.

About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, Northera(TM) (droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Northera, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, our need to raise additional operating capital in the future, our history of losses, competition, market acceptance for our products if any are approved for marketing, and reliance on key personnel including specifically Dr. Pedder.
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« Reply #71 on: August 19, 2010, 11:34:34 am »

A Randomized Trial of Tai Chi for Fibromyalgia

Chenchen Wang, M.D., M.P.H., Christopher H. Schmid, Ph.D., Ramel Rones, B.S., Robert Kalish, M.D., Janeth Yinh, M.D., Don L. Goldenberg, M.D., Yoojin Lee, M.S. and Timothy McAlindon, M.D., M.P.H.


August 19, 2010
Background

Previous research has suggested that tai chi offers a therapeutic benefit in patients with fibromyalgia.
Methods

We conducted a single-blind, randomized trial of classic Yang-style tai chi as compared with a control intervention consisting of wellness education and stretching for the treatment of fibromyalgia (defined by American College of Rheumatology 1990 criteria). Sessions lasted 60 minutes each and took place twice a week for 12 weeks for each of the study groups. The primary end point was a change in the Fibromyalgia Impact Questionnaire (FIQ) score (ranging from 0 to 100, with higher scores indicating more severe symptoms) at the end of 12 weeks. Secondary end points included summary scores on the physical and mental components of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). All assessments were repeated at 24 weeks to test the durability of the response.
Results

Of the 66 randomly assigned patients, the 33 in the tai chi group had clinically important improvements in the FIQ total score and quality of life. Mean (±SD) baseline and 12-week FIQ scores for the tai chi group were 62.9±15.5 and 35.1±18.8, respectively, versus 68.0±11 and 58.6±17.6, respectively, for the control group (change from baseline in the tai chi group vs. change from baseline in the control group, −18.4 points; P<0.001). The corresponding SF-36 physical-component scores were 28.5±8.4 and 37.0±10.5 for the tai chi group versus 28.0±7.8 and 29.4±7.4 for the control group (between-group difference, 7.1 points; P=0.001), and the mental-component scores were 42.6±12.2 and 50.3±10.2 for the tai chi group versus 37.8±10.5 and 39.4±11.9 for the control group (between-group difference, 6.1 points; P=0.03). Improvements were maintained at 24 weeks (between-group difference in the FIQ score, −18.3 points; P<0.001). No adverse events were observed.
Conclusions

Tai chi may be a useful treatment for fibromyalgia and merits long-term study in larger study populations. (Funded by the National Center for Complementary and Alternative Medicine and others; ClinicalTrials.gov number, NCT00515008.)
Source Information

From the Division of Rheumatology (C.W., R.K., J.Y., T.M.) and the Institute for Clinical Research and Health Policy Studies (C.H.S., Y.L.), Tufts Medical Center, Tufts University School of Medicine; and Mind–Body Therapies (R.R.) — both in Boston; and Newton–Wellesley Hospital, Newton, MA (D.L.G.).

Address reprint requests to Dr. Wang at the Division of Rheumatology, Tufts Medical Center, 800 Washington St., Box 406, Tufts University School of Medicine, Boston, MA 02111, or at cwang2@tuftsmedicalcenter.org.
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« Reply #72 on: October 12, 2010, 08:36:02 am »

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia

FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia
-- Company to host conference call on Monday, October 11, 2010 at 8:30 AM ET --

PALO ALTO, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has sent the company a complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The CRL states that the FDA cannot approve the NDA in its present form. In the letter, the FDA discusses a number of topics, including the need for additional clinical studies, the appropriate patient population, methods for ensuring safe use, and the proposed REMS, concentration and trade name for the product.

"We have requested a meeting with FDA in order to discuss and clarify the contents of the CRL and will then evaluate our next steps for JZP-6," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA."

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today (October 11) at 8:30 AM Eastern Time/ 5:30 AM Pacific Time to discuss this release and respond to investor questions. The live webcast may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary.

Investors may participate in the conference call by dialing 866-700-6067 in the U.S., or 617-213-8834 outside the U.S., and entering passcode 43104766.

An archived version of the webcast will be available for at least one week on the investors section of the Jazz Pharmaceuticals' website at www.jazzpharmaceuticals.com.

Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information see www.jazzpharmaceuticals.com.

This press release contains forward-looking statements, including but not limited to statements related to Jazz Pharmaceuticals' JZP-6 (sodium oxybate) product candidate, including statements related to Jazz Pharmaceuticals' plans to meet with the FDA, the outcome of any such meeting and all future regulatory matters, including its future approval and the future development of JZP-6. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the uncertain and time-consuming regulatory approval process for JZP6, risks related to potential further development of JZP-6, and other risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on August, 11, 2010. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

CONTACT: Ami Knoefler, Executive Director, Investor Relations & CorporateCommunications of Jazz Pharmaceuticals, Inc., +1-650-496-2947, investorinfo@jazzpharmaceuticals.com

Web site: http://www.jazzpharmaceuticals.com/
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« Reply #73 on: October 17, 2010, 03:09:05 pm »

Fibromyalgia patients have more “connectivity” between brain networks and regions of the brain involved in pain processing, which may help explain why sufferers feel pain even when there is no obvious cause, a new study suggests.

Researchers had 18 women with fibromyalgia undergo six-minute fMRI brain scans, and compared their results to women without the condition.

Participants were asked to rate the intensity of the pain they were feeling at the time of the test. Some people reported feeling little pain, while others reported feeling more intense pain.

Brain scans showed the connectivity, or neural activity, between certain brain networks and the insular cortex, a region of the brain involved in pain processing, was heightened in women with fibromyalgia compared to those without the condition.

The connectivity to the insular cortex was even stronger in participants who reported feeling more intense pain compared to milder pain, said study author Vitaly Napadow, a neuroscientist at Massachusetts General Hospital.

“We took advantage of the fact that there is a large discrepancy in the amount of pain patients happen to be in at the time they come in. Unfortunately some patients come in, and they are in a lot of pain. Other patients come in and they are not in pain,” Napadow said.

The study, by researchers from Massachusetts General Hospital and the University of Michigan, is published in the August issue of Arthritis & Rheumatism.

Fibromyalgia is a chronic pain syndrome that’s characterized by widespread pain, fatigue, insomnia, and the presence of multiple tender points. The syndrome can also cause psychological issues, including anxiety, depression and memory and concentration problems, sometimes called the “fibromyalgia fog.”

Prior research has shown that people with fibromyalgia feel a given amount of pain more intensely than others, Napadow explained. In other words, studies have shown a typical person might rate a painful stimuli a “one” on a scale or one to 10, while a person with fibromyalgia might rate the pain a 5 or higher.

The new study is different in that fibromyalgia patients’ pain responses were measured while they were at rest and not being exposed to anything painful, Napadow said.

The brain networks involved were the default mode network (DMN) and the right executive attention network (EAN). The DMN is involved in “self-referential thinking,” when you think about yourself or what’s happening to you, Napadow explained.

The EAN is involved in working memory and attention. When that brain network is occupied, or distracted, by pain, it may explain some of the cognitive issues that fibromyalgia patients experience, Napadow said.

Dr. Philip Mease, director of rheumatology research at Swedish Medical Center in Seattle and a member of the National Fibromyalgia Association medical advisory board, said the study provides insight into what may be going on in the brains of people with fibromyalgia.

“This work shows there is increased connectivity between different brain centers that connect the purely sensory pain processing centers of the brain with some of the emotional and evaluative parts of the brain, or areas of the brain that take a sensory stimulus and say, “How do I interpret this? How do I feel about this’?” Mease said.

For years, fibromyalgia has been a highly misunderstood syndrome, with some doctors doubting it even existed, and others attributing the pain to depression or other psychological issues.

That began to change early this decade, when brain scans showed pain-processing abnormalities in fibromyalgia patients, Mease said.

“That first neuroimaging study really demonstrated fibromyalgia patients were different than normal individuals, and at a neurobiological level, were truly experiencing more pain at lower intensities,” Mease said.

The new research moves understanding of the condition a step further, by exploring what’s happening in the brain during a resting state.

“Regardless of poking or prodding them, this study is trying to get at an understanding of what is crackling in the brain, intrinsically, such that they have this higher sensitivity,” Mease said.

About 10 million Americans are believed to have fibromyalgia, almost 90 percent of whom are women, according to the National Fibromyalgia Association. Sufferers report a history of widespread pain in all four quadrants of the body for at least three months, and pain in at least 11 of 18 “tender points.”


More information

Read more about fibromyalgia at the National Fibromyalgia Association.

SOURCES: Vitaly Napadow, Ph.D, neuroscientist and assistant professor, radiology, Massachusetts General Hospital, Harvard Medical School, Boston; Philip Mease, M.D., director, rheumatology research, Swedish Medical Center, Seattle, and member, National Fibromyalgia Association medical advisory board; August 2010 Arthritis & Rheumatism
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« Reply #74 on: January 14, 2011, 08:09:57 am »

A meta-analysis of pain response in the treatment of fibromyalgia
Pain Practice, 01/14/2011  Evidence Based Medicine  Clinical Article

Roskell NS et al. – All eight active treatments displayed evidence suggesting improvement over placebo in the treatment of pain in patients suffering from fibromyalgia. Indirect comparison of active treatments found no strong differences.

Methods
Conducted meta-analysis of 21 clinical trials to estimate treatment differences vs. placebo, separately, for duloxetine, fluoxetine, gabapentin, milnacipran, pramipexole, pregabalin, either of 2 tricyclic antidepressants, and tramadol plus paracetamol
Direct treatment comparisons using mixed treatment comparisons methodology conducted for all pairwise comparisons
Pain response analyzed as improvement of at least 30%, and separately of 50%, from baseline

Results
When compared with placebo, statistically significant pain responses (improvement of 30% and 50%) observed for patients treated with duloxetine, milnacipran 200 mg/day, pregabalin 300 or 450 mg/day, and tramadol plus paracetamol
Treatment with fluoxetine, gabapentin, or milnacipran 100 mg/day resulted in significant findings for 30% improvement in pain response
Meta-analysis showed statistically increased risk of discontinuation because of adverse events for milnacipran 100 and 200 mg/day (both P < 0.001), and pregabalin 300 and 450 mg/day (P = 0.009 and P < 0.001)
All other treatments, except fluoxetine, showed numerically increased risk over placebo for discontinuation because of adverse events
In indirect comparisons, no pairwise comparison of active treatments reached statistical significance for either pain response end point
SOURCE: MDLnx
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