FDA Raises Concerns About Fibromyalgia Drug
The Wall Street Journal (8/19, Dooren) reports that the FDA revealed safety concerns about Jazz Pharmaceuticals Inc.'s potential fibromyalgia drug Rekinla (sodium oxybate), which faces a review on Friday from the FDA's arthritis and drug-safety advisory committees. The drug is currently approved to treat narcolepsy under the brand name Vyrem, but would be dosed in a different way to treat fibromyalgia. Jazz also is proposing to sell the drug under a different restricted distribution program than currently used for narcolepsy, which would involve 15 specialty pharmacies, but the FDA said that two restricted distribution programs may create confusion among prescribers and be burdensome to the healthcare system. The FDA also said it was concerned about having two different brand names for the drug.