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12:00 AM
Dec 22, 2008
 |  BioCentury  |  Product Development

Putting fibromyalgia to sleep

Two drugs are approved in the U.S. to treat fibromyalgia. But given the long list of symptoms associated with the disorder, Jazz Pharmaceuticals Inc. believes there is plenty of room for new drugs to help manage the pain and fatigue that characterize the disease. The company now has positive data in hand from its first Phase III trial of JZP-6, and anticipates it will complete enrollment in a second Phase III study by year end.

In 1990, the American College of Rheumatology developed criteria for diagnosing fibromyalgia as a clinical condition characterized by a nebulous combination of symptoms including chronic pain, allodynia (pain from a non-noxious stimulus to ordinary skin), fatigue, sleep disturbances and muscle aches. For many years, patients made do with pain drugs, antidepressants, sleep medicines and muscle relaxants to address their symptoms, said Diane Guinta, VP of clinical R&D at Jazz.

According to Andrew Holman, a clinical professor of medicine at the University of Washington, the treatment paradigm has been transformed since 2007, as a pair of drugs approved for other conditions...

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