FDA panel rejects Jazz drug for pain condition
WASHINGTON
Federal health experts said Friday the risks of a sleep drug from Jazz Pharmaceuticals outweigh its benefits for treating the chronic pain disorder fibroymalgia.
The Food and Drug Administration's panel of outside advisers voted 20-2 against recommending approval of the company's application to market sodium oxybate for fibromyalgia, according to an agency spokeswoman. Fibromyalgia is a little-understood condition characterized by muscle pain and fatigue.
The FDA gives weight to the panel's recommendations, but is not required to follow them. The agency is scheduled to make its final ruling on the drug by Oct. 11.
Jazz already markets the drug as a treatment for excessive sleepiness under the brand name Xyrem. The drug is considered a "controlled substance," by the U.S. drug enforcement authorities because its active ingredient has been used as an illegal stimulant and a date rape drug. Access to the drug is limited and doctors must register with the government before prescribing it.
Earlier in the week, FDA scientists expressed concern about expanding the drug's approval to a much wider population.
Between 6 million and 12 million people in the U.S. have fibromyalgia, more than 80 percent of them women, according to the American College of Rheumatology.
Jazz said it would distribute the drug through 15 specialty pharmacies, if it were approved for fibromyalgia. Jazz would market the drug under the brand-name Rekinla.
Xyrem posted fiscal year 2009 sales of $97 million.
17 months ago
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