Pierre Fabre Médicament : JONCIA® milnacipran treating fibromyalgia in Australia

On November 17 in Australia, Pierre Fabre Médicament obtained marketing authorization for Joncia® milnacipran in the treatment of fibromyalgia.

Australian drug regulation agency the Therapeutic Goods Administration (TGA) has granted Pierre Fabre Médicament marketing authorization for Joncia® milnacipran, a molecule used in the treatment of fibromyalgia. First discovered by Pierre Fabre's research teams, milnacipran has since been developed for this indication in collaboration with Cypress Bioscience (acquired by Royalty Pharma) and Forest Laboratories.

Approval was granted on the basis of three 3-month Phase III clinical trials conducted in the United States and Europe. These studies, involving over 3,000 patients evaluated using a self-assessment questionnaire, revealed that 100 mg and 200 mg doses of milnacipran resulted in a clinically significant reduction in pain, an overall improvement in symptoms, and a significant improvement in fatigue and sleep. In addition Milnacipran was generally well tolerated with most adverse events being recorded as mild to moderate, and the TGA has announced a positive Joncia® milnacipran benefit/risk ratio... Pierre Fabre Médicament's Press Release -

Chelsea Therapeutics : New Patent for Use of Droxidopa in Fibromyalgia

Sept. 6, 2011 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,008,285 entitled "Droxidopa and pharmaceutical composition thereof for the treatment of fibromyalgia." The claims of the patent are related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications, to patients diagnosed with fibromyalgia. Chelsea recently completed enrollment of 120 patients in its Phase II trial of droxidopa for the treatment of fibromyalgia. Top-line results of the trial are expected by the end of the year.

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... Chelsea Therapeutics' Press Release -

Pico-Tesla : pilot study of Magneceutical® Therapy for fibromyalgia

Dec. 15, 2010 — Pico-Tesla, The Magneceutical® Company, announced that it has commenced a randomized, double-blind, placebo-controlled pilot study of 30 patients who have fibromyalgia. The pilot study seeks to determine whether the application of magnetic fields generated by Pico-Tesla’s patented Resonator™ system can be effective as an adjunctive therapy to oral medications in ameliorating the symptoms of fibromyalgia.

The study will be coordinated by Miguel Trevino, M.D., Medical Director, Innovative Research of West Florida, Clearwater, Fla. Dr. Trevino is certified to practice medicine by the American Board of Internal Medicine. Innovative Research of West Florida is a leading Clinical Research Site... Pico-Tesla's Press Release -

TONIX Pharmaceuticals : Analysis of Phase 2a Study of Very Low Dosage Cyclobenzaprine in Fibromyalgia Syndrome (FMS)

November 9, 2010 – For the First Time, Correlation Demonstrated between Sleep Stability and Reductions of Fatigue in FMS - Results Presented at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) 2011 Annual Scientific Meeting - TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals), a specialty central nervous system (CNS) pharmaceutical company, announced results of a new analysis of a Phase 2a study, which previously demonstrated reduced pain, fatigue and tenderness in patients with Fibromyalgia Syndrome (FMS) following bedtime administration of very low dosage (VLD) cyclobenzaprine (CBP). According to the analysis, VLD CBP treatment was associated with reductions in an objective measure of non-REM sleep instability, referred to as Cyclic Alternating Patterns (CAP) A2 & A3; these reductions were statistically significantly correlated with diminished pre-sleep/p.m. fatigue in FMS. The findings are the subject of a poster presentation at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) 2011 Annual Scientific Meeting.

Dr. Harvey Moldofsky, President and Medical Director, Centre for Sleep and Chronobiology, Toronto, Canada, and lead author of the study, commented, “Current treatments for FMS are inadequate, and there is substantial interest in the impact of improving sleep quality in these patients. Our analysis demonstrates improvements in FMS fatigue can be correlated with a therapeutic modality that normalizes nonrestorative sleep, and we believe this provides additional confirmation of the central importance of poor sleep quality in FMS.”... TONIX Pharmaceuticals' Press Release -

Adeona : $17.5 Million Corporate Partnership with Meda AB for the Development and Commercialization of Flupirtine for Fibromyalgia

May 7, 2010 - Adeona to Receive Royalties on Potential Billion Dollar indication - Meda to Assume All Future Development Costs - Adeona Pharmaceuticals, Inc., (AMEX: AEN) announced that it has entered into a corporate partnership with Sweden-based Meda AB, to develop flupirtine for the treatment of fibromyalgia syndrome which contemplates the payment to Adeona of up to $17.5 million in upfront and milestone payments, plus royalties.

Under the terms of the agreement, Adeona has granted Meda an exclusive sublicense to all of Adeona’s patents covering the use of flupirtine for fibromyalgia. These patents have issued in the U.S. and are pending in Canada and Japan (the “Territory”).

Meda will assume all future development costs for the commercialization of flupirtine for fibromyalgia. Adeona received an up-front payment of $2.5 million and is entitled to milestone payments of $5 million upon filing of a New Drug Application with the Food and Drug Administration for flupirtine for fibromyalgia and $10 million upon marketing approval. Adeona is also entitled to receive royalties of 7% of net sales of flupirtine approved for the treatment of fibromyalgia covered by issued patent claims in the Territory. Adeona will share such royalties equally with Adeona’s university licensor.

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. Fibromyalgia affects an estimated 2-4% of the population worldwide, including an estimated 4 million patients in the United States... [PDF] Adeona Pharmaceuticals' Press Release - Meda's Press Release -

Jazz Pharmaceuticals : Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia

Aug 20, 2010 - Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the Joint Advisory Committee of the U.S. Food and Drug Administration (FDA), including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of fibromyalgia with the currently proposed Risk Evaluation Mitigation Strategy (REMS).

"While we are disappointed with the recommendation of the Joint Advisory Committee, we plan to work closely with FDA on the continuing review of our new drug application (NDA)," said Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, Inc. "We will carefully consider the input of the Committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way."... Jazz Pharmaceuticals' Press Release -

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

July 1, 2010 - 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... Chelsea Therapeutics' Press Release -

MicroLight : laser treats fibromyalgia

April 19, 2010 - MicroLight Corporation of America : laser treats fibromyalgia - Fibromyalgia is a condition in which the brain processes pain in an abnormal way, resulting in chronic, widespread muscular-skeletal pain and chronic fatigue. This condition effects millions of Americans and has been poorly understood and under diagnosed, resulting in billions of dollars in cost to our health care system. In the past, treatments have been primarily with medications; often side effects can make the symptoms worse.

The LOW LEVEL LASER used is the Patented ML830® which was the first “low level Laser” approved by the FDA in 2002 to treat pain and swelling. The Laser produces no heat to the tissue and causes vassal dilation in the Micro Capillary bed, the treatment is PAINLESS WITH NO SIDE EFFECTS... MicroLight Corporation of America's Press Release -

Forest Laboratories and Cypress Bioscience : FDA Defers Final Action on milnacipran New Drug Application

Oct 20, 2008 - Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) (the "Companies") announced that the U.S. Food and Drug Administration (FDA) has advised the Companies that it was not able to take final action by the scheduled Prescription Drug User Fee Act action date of October 18, 2008, on their New Drug Application for milnacipran, a selective serotonin and norepinephrine reuptake inhibitor for the management of fibromyalgia.

The FDA has not requested any additional information from the Companies but did indicate that a clinical data question related to the NDA submission required confirmation. The FDA indicated that their assessment could be completed in a matter of weeks, but could not confirm specific timing. The FDA could not provide further information as to the reason for the delay. The Companies continue to plan for a first quarter 2009 product launch meeting... Forest Laboratories' Press Release - [PDF] Cypress Bioscience's Press Release -

Fralex Therapeutics : update on timing of interim analysis results

September 25, 2008 – Fralex Therapeutics Inc. (TSX:FXI) , a medical technology company developing a non-invasive neuromodulation device, provided an update on receiving results of the interim analysis for the RELIEF pivotal study. The trial is investigating the use of Complex Neural Pulse or CNPTM therapy for the relief of chronic pain associated with fibromyalgia.
The Independent Data Monitoring Committee (“DMC”) is scheduled to meet on October 2, 2008, to review data from the first 100 patients enrolled in the trial... [PDF] Fralex Therapeutics's Press Release -

Chelsea Therapeutics : MHRA Approval to Begin Phase II Trial of Droxidopa in Fibromyalgia

July 23, 2008 - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) has received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase II trial of Droxidopa, alone and in combination with carbidopa, for the treatment of 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... Chelsea Therapeutics' Press Release -

Lilly : FDA Approves Cymbalta for the Management of Fibromyalgia

June 16, 2008 - The U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company (NYSE: LLY) announced. Cymbalta is the first serotonin- norepinephrine reuptake inhibitor with proven efficacy for reducing pain in patients with fibromyalgia. The fibromyalgia indication represents the second FDA-approved use for Cymbalta for a pain disorder, demonstrating the medication's analgesic effect... Lilly's Press Release -

Pipex Pharmaceuticals : Oral Flupirtine Receives IND with FDA For Phase II Clinical Trial For Fibromyalgia

April 21, 2008 - Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, today announced that the United States FDA has opened an Investigational New Drug Application (IND) to conduct a double-blind, randomized, placebo-controlled Phase II clinical trial of oral flupirtine for the treatment of fibromyalgia, a rheumatic pain disease which affects an estimated 6 million Americans. Lyrica®, the only FDA-approved medication for the treatment of fibromyalgia amongst other indications, recorded $1.8 billion in sales during 2007, with 47 percent annual growth...
...This phase II clinical trial is designed as a double-blind, placebo controlled phase II clinical trial which would evaluate safety and efficacy of oral flupirtine vs. placebo in fibromyalgia patients. This phase II clinical trial is intended to enroll up to 90 subjects and treat subjects for up to 90 days and the primary endpoint will be a reduction in musculoskeletal pain and the overall symptoms of fibromyalgia. Secondary outcomes of the study will be a reduction in the severity of mood, fatigue, cognitive symptoms, and sleep disturbance, as well as improve the overall level of functioning... Pipex Pharmaceuticals' Press Release -

Pfizer : Lyrica Reduced Pain of Fibromyalgia in Patients Regardless of Symptoms of Anxiety or Depression

April 16, 2008 - -Pfizer’s Lyrica reduced pain of fibromyalgia in patients regardless of whether they experienced symptoms of anxiety or depression at the beginning of the study, according to a pooled analysis presented today at the American Academy of Neurology annual meeting. The analysis, which looked at data pooled from previous clinical trials, also showed that patients’ self-reported improvements were more closely associated with improvements in pain and sleep than with improvements in fatigue or symptoms of anxiety or depression.

Fibromyalgia is the most common, chronic widespread pain condition in the United States and is thought to result from neurological changes in how patients perceive pain. Fibromyalgia is usually accompanied by poor sleep, stiffness and fatigue... Pfizer's Press Release -