Milnaciprin under FDA Review Process

Karen Lee Richards Health Guide
  • I've been watching a medication called milnaciprin for several years as it's made its way through numerous clinical trials in its quest to be approved for the treatment of fibromyalgia.  Milnaciprin is a serotonin and norepinephrine reuptake inhibitor (SNRI).  Although it is approved in many countries for the treatment of depression, it is not currently available in the U.S., and therefore cannot yet even be prescribed off-label.

    Milnaciprin was developed by Cypress Bioscience and licensed to Forest Laboratories in the U.S. and Canada.  Late in 2007 Forest and Cypress filed an application for FDA approval of milnaciprin for the treatment of fibromyalgia.  Predictions are that it has a 70 – 80 percent chance of being approved within the next month or two.  The worst-case scenario is that it might take up to nine months to get approval. 

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    If and when milnaciprin is approved, it will become the third drug to receive FDA approval for the treatment of fibromyalgia.  It will follow Lyrica (pregabalin), an anti-convulsant medication approved in June 2007, and Cymbalta (duloxetine), another SNRI approved in June 2008.  We waited for so many years to finally break through that barrier and get a medication approved for FM.  It's so exciting now to think that soon we will have three! 

    While I'm certainly happy that we have more treatment options available to us, I think I'm even happier that fibromyalgia is finally receiving the legitimacy and credibility it deserves.  Thanks to Pfizer's TV ad campaign promoting Lyrica, more and more people are accepting that it is a real illness and acknowledging that our pain is indeed real.  And doctors are gradually becoming more comfortable treating FM patients because there are now approved medications they can prescribe. 

    All in all, a very good thing.


    To learn more about the various medications used to treat FM, read: “Medications Prescribed for Fibromyalgia”

Published On: September 29, 2008