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Phase 3 Study of Milnacipran Fails To Achieve Statistical Significance
In an analysis using the FDA-recommended Baseline Observation Carry- forward (BOCF)(4) analysis the p-value for patients receiving 200 mg per day of milnacipran was 0.048. Although the BOCF analysis yielded statistically significant results, the FDA may not accept this as a registration study.
The magnitude of the treatment effect observed in the three-month study results was maintained at the six-month analysis (p=0.053 and 0.067 for LOCF and BOCF analyses respectively), indicating a durable response to milnacipran treatment.
An additional endpoint of fibromyalgia syndrome, which is a composite of the primary endpoint as well as a physical function assessment, was also evaluated. The results of this analysis were not statistically significant compared to placebo at either the three or six month timeframe.
Upon further analysis, the Companies will be in a position to better assess what impact these results will have on the timing of a New Drug Application (NDA).
Milnacipran was generally well tolerated, with the majority of patient withdrawals occurring early in the trial. The adverse event profile was generally consistent with that seen in the previous worldwide experience with milnacipran, as well as in the Phase II trial. The most common adverse events leading to withdrawal among the milnacipran treated patients were nausea 6%, heart rate increase 2%, headache 2%, and depression 2%.
Milnacipran is the first of a new class of agents known as norepinephrine serotonin reuptake inhibitors, or NSRIs, which exerts its effect by preferentially inhibiting the reuptake of norepinephrine over serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for the treatment of non-pain indications in 32 countries and has been used safely by more than 3 million patients during more than six years of commercial availability outside the U.S. Milnacipran is being developed for fibromyalgia in the United States market jointly by Forest and its licensor, Cypress Biosciences, Inc.
About Fibromyalgia (FMS)
FMS is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. According to the American College of Rheumatology, FMS is estimated to affect six to twelve million people in the United States. FMS is most often diagnosed in the primary care setting and in addition is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this syndrome, there are no treatments specifically approved for FMS in the United States or elsewhere. For more information about fibromyalgia, visit http://www.fmsresource.com/.
Source: Forest Laboratories, Inc. and Cypress Bioscience, Inc.