Milnacipran, a drug new to the U.S., is now undergoing the FDA process for being approved to treat fibromyalgia syndrome (FMS). Made by Forest Laboratories, Inc. and Cypress Bioscience, Inc., milnacipran is an antidepressant similar to Cymbalta (duloxetine), which is the second drug the FDA approved for treating FMS.
Both drugs increase levels of the neurotransmitters serotonin and norepinephrine, which can be low in people with fibromyalgia, but milnacipran is the first drug reported to increase norepinephrine more than serotonin.
The New Drug Application, filed in December of 2007, includes data from two phase III trials involving more than 2,000 patients. The company says data show milnacipran was more effective than a placebo and was well tolerated. There were no deaths and the majority of side effects were described as mild to moderate.
Milnacipran is sold in Europe under than names Dalcipran and Ixel. has been on the market for a decade and is approved for depression in more than 50 countries.
Pfizer's Lyrica (pregabalin) was the first drug to become FDA approved for fibromyalgia.
Sources:
2007 Forest Laboratories, Inc.,
Press Release.
2007 MedPage Today, LLC. All Rights Reserved. ACR: Duloxetine Falls Short in Phase III Fibromyalgia Trial
