European Regulators Say "No" to Cymbalta for Fibromyalgia

NEWSBRIEF: The European panel that regulates drugs has decided not to approve Cymbalta (duloxetine) as a fibromyalgia treatment. The panel made the decision after reviewing data from clinical studies on Cymbalta but has not given specifics as to why it decided against the drug, which already is in use in Europe for diabetic neuropathy, depression, generalized anxiety disorder, and stress urinary incontinence.

So far, no medication is approved in Europe for fibromyalgia. Cymbalta and Lyrica (pregabalin) are approved for fibromyalgia in the U.S., and an FDA decision is expected on milnacipran by the end of 2008.

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