UPDATE:FDA Raises Safety Concerns About Proposed Jazz Fibromyalgia Drug

The U.S. Food and Drug Administration raised safety concerns about a proposed Jazz Pharmaceuticals Inc. (JAZZ) drug to treat the pain disorder fibromyalgia, including the potential for misuse and abuse of the product.

The drug, which is currently sold under the brand name Xyrem to treat narcolepsy, faces a review Friday during a joint meeting of the FDA's arthritis and drug safety advisory committees. The FDA posted background documents prepared for the meeting on its website Wednesday.

Xyrem is known by its generic name, sodium oxybate. However, the company is proposing to sell the product as Rekinla to treat fibromyalgia. It would be dosed in a different manner than currently used for narcolepsy, a condition marked by excessive daytime sleepiness.

Sodium oxybate is sold as part of a controlled distribution system through a central pharmacy that was designed to limit abuse and misuse of the product. In an illegal form, sodium oxybate is known as the street drug GHB.

Patients and doctors are also required to be enrolled in the program in order to prescribe and receive Xyrem, which is an oral drug taken twice in the evening. The product carries the FDA's toughest boxed warning stating the drug is a central nervous system depressant "with abuse potential." The product label also warns the drug has been associated with confusion, depression and other neuropsychiatric events.

Jazz is proposing to sell the product under a different restricted distribution program than currently used for narcolepsy which would involve 15 specialty pharmacies.

The FDA said the existence of two restricted distribution programs may create confusion among prescribers and might be burdensome to the health care system. The agency also said it was concerned that having two different brand names for the product could lead to medication errors. Additionally, FDA said it was concerned there was a "higher risk" for dosing errors if the proposed 375 milligram per millimeter dose is used for fibromyalgia patients. The drug is currently sold in a 500 milligram concentration to treat narcolepsy.

However, the agency said clinical data submitted by Jazz suggests sodium oxybate is effective at reducing fibromyalgia pain. The agency said the data wasn't strong enough to show that sodium oxybate improved sleep in fibromyalgia patients.

The FDA has asked the panel to vote on whether it thinks sodium oxybate should be approved to treat fibromyalgia. The FDA usually follows its panels' advice, but isn't required to.

Fibromyalgia is a poorly understood pain condition which is believed to affect three to six million Americans, mostly women. Fibromyalgia is marked by widespread muscle pain, tenderness and fatigue. The condition traditionally has been treated with a mix of painkillers and antidepressants.

Since 2007 the FDA has approved three products to treat fibromyalgia: Pfizer Inc.'s (PFE) Lyrica; Eli Lilly & Co.'s (LLY) Cymbalta; and Savella from Forest Laboratories Inc. (FRX) and Cypress Bioscience Inc. (CYPB).

In a document also posted to FDA's website, Jazz said no single treatment addresses all of the symptoms of fibromyalgia and that sodium oxybate would provide another option.

"We believe that the magnitude and persistence of benefit for multiple symptoms of fibromyalgia clearly outweigh the product's risks," the company said, noting that the proposed risk management program is designed to mitigate the risks.

Indeed, the FDA said the current risk-management program for Xyrem has "reasonably accomplished" the goal of preventing misuse and abuse of the product. However, the agency said use of the product is currently low with about 10,000 to 12,000 patients per year and use of the product would expand if approved for fibromyalgia.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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