As of early 2009, the U.S. FDA was reviewing the New Drug Application (NDA) for milnacipran as a fibromyalgia treatment. The administration missed its October 2008 deadline for making a decision, saying only that it needed more time to review data.
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. Further studies have supported these results.
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 people unable to tolerate Cymbalta or Lyrica (pregabalin). Cymbalta and Lyrica are currently the only drugs FDA approved for treating fibromyalgia pain.
