Milnacipran for Treating Fibromyalgia - Still Awaiting a Decision

New Drugs of 2009 Series: Milnacipran

When a New Drug Application is submitted to the FDA, there's a deadline for when the agency is supposed to make a decision. However, the deadline for approving or denying milnacipran as a fibromyalgia treatment came and went in October 2008. At that time, the FDA said it needed more time to review data but did not give a timeline. Since then, there's been no word. Regardless, we should hear early this year about whether milnacipran has passed muster.

Milnacipran is fairly similar to Cymbalta (duloxetine), which was the second drug to be FDA approved for fibromyalgia. Cymbalta is an SNRI (serotonin norepinephrine reuptake inhibitor), which boosts available levels of serotonin and norepinephrine in the brain. To date, all FDA-approved drugs in this class raise serotonin more than norepinephrine, but milnacipran favors norepinephrine.

If approved, milnacipran would be making its debut on the U.S. market. As an antidepressant, it's been used prescribed for more than a decade in 50 different countries. It's got a good track record for being well tolerated. When I've written about it here before, I've gotten comments from people involved in the U.S. clinical trials who say they can't wait to get back on this drug.

Are you waiting for word on milnacipran? Have you talked to your doctor about it? Have you taken it? Share your experiences here, or in About.com's Fibromyalgia & Chronic Fatigue Syndrome community forum (under Newsletter & Blog Topics.)

Suggested Reading:

• The Multidisciplinary Approach to Treating Fibromyalgia
• Fibromyalgia Drugs
• Supplements for Managing Symptoms

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