FDA Says No To Jazz Pharma Fibromyalgia Drug

PALO ALTO, Calif. (AP) -- Federal regulators want additional clinical studies of a fibromyalgia drug candidate from Jazz Pharmaceuticals and the failure to get a go-ahead sent company shares down 11 percent before the market opened Monday.

New clinical trials could take years to complete, delaying approval for the drug JZP-6 and significantly increase expenses for Jazz. The Food and Drug Administration also wants more information on which patients would benefit, more details about the company's strategy for evaluating and reducing the drug's risks and other data. The chemical name of the drug is sodium oxybate.

Jazz said it will meet with the FDA to discuss the issues in the agency's response. The company filed for marketing approval of JZP-6 in February, and Jazz's website says JZP-6 is the company's most advanced drug candidate.

In August, an FDA advisory panel recommended the drug not be approved. By a wide margin, the panel said the drug's safety risks did not justify its approval.

Jazz Pharmaceuticals Inc. has two products on the market. It sells Xyrem for daytime sleepiness in patients with narcolepsy, as well as for cataplexy, a condition associated with narcolepsy that causes sudden and brief losses of muscle control. Jazz also markets Luvox for obsessive compulsive disorder and social anxiety disorder.

Company shares slumped 55 cents, or 5.4 percent, to $9.56 premarket trading. The shares have ranged from $6.01 to $13.95 in the last year.
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