FDA has concerns about misuse of Jazz Pharmaceuticals drug if cleared for pain ailment

FDA eyes Jazz Pharmaceuticals fibromyalgia drug

WASHINGTON — Shares of Jazz Pharmaceuticals Inc. jumped Wednesday after federal health officials said one of its drugs appears effective for treating a chronic pain disorder.

The Food and Drug Administration posted its review online, saying Jazz’s drug sodium oxybate effectively treated pain from fibromyalgia in two company-run studies. However, regulators have concerns about the misuse and abuse of the drug, which has been used as an illegal stimulant and a date rape drug.

Fibromyalgia is characterized by widespread muscle pain and other symptoms including fatigue, headache and depression.

Jazz Pharmaceuticals, based in Palo Alto, Calif., already markets the drug under the brand name Xyrem, as a treatment for excessive sleepiness. Xyrem is considered a “controlled substance,” by the U.S. drug enforcement regulators, and patients and doctors prescribing the drug must register with the government. Between 2002 and 2009, the FDA identified just five cases of misuse or abuse of the drug

But FDA reviewers cautioned that an approval for fibromyalgia would greatly expand the drug’s patient population, making it harder to control. Drug reviewers recommended a strict distribution and monitoring plan “to positively identify and document cases of abuse, misuse, diversion and overdose.”

On Friday, a panel of outside FDA experts will weigh in on whether the drug should be approved for fibromyalgia. The FDA is not required to follow the group’s advice, though it often does.

WBB Securities analyst Andrew Forman notes that Jazz already has a solid track record for managing the drug’s risks, since Xyrem has been on the market since 2002.

“Strong data from an already approved drug with a strong ‘risk evaluation and mitigation’ program that has worked for the past seven years should provide the panel with the comfort it needs for a favorable vote,” Forman wrote in a recent analyst note.

The American College of Rheumatology estimates that between 6 million and 12 million people in the U.S. have fibromyalgia, more than 80 percent of them women.

Shares of Jazz Pharmaceuticals rose 36 cents, or 3.5 percent, to close at $10.61 on Wednesday.

(This version CORRECTS that meeting of FDA panel is Friday)