Posted by MERM on 6/8/2008, 10:03 am
FDA Moves Forward on New Drug Application for Fibromyalgia
Decision on Milnacipran Expected This Fall
The U.S. FDA says it will review the New Drug Application (NDA) for milnacipran as a fibromyalgia treatment. The standard review timeline is 10 months, which means we could expect a decision by the end of October.
Forest Laboratories, Inc. and Cypress Bioscience, Inc. submitted the NDA for milnacipran based on findings that people with fibromyalgia who took milnacipran had less pain, more physical function and a positive impression of being better overall.
Milnacipran is an antidepressant similar to Cymbalta (duloxetine), as both drugs raise levels of the neurotransmitters serotonin and norepinephrine. (Both are generally low in people with fibromyalgia, and also in many people with chronic fatigue syndrome.) Milnacipran, however, is the only drug in its class that raises norepinephrine more than serotonin. Outside the U.S., it's been on the market for about a decade and is available in more than 50 countries. It's currently not approved for any use in the U.S.
Milnacipran's side effects reportedly are milder than many drugs in its class, which could make it a viable alternative to Lyrica (pregabalin) for people who don't tolerate the drug well. Lyrica currently is the only drug approved for fibromyalgia. Cymbalta also is awaiting FDA review of its NDA.
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