Health Inc.

Drug Made Infamous By Date Rapes Gets Second Look For Fibromyalgia

The powerful depressant known as GHB, which was put under the strictest government regulation in 2000 after it was found to have been used as a knockout potion in sexual assaults, is getting a new lease on life.

A company called Jazz Pharmaceuticals wants to sell the stuff under the brand-name Rekinla as a treatment for fibromyalgia. A panel of experts will meet this Friday to review the evidence in support of the drug and make a recommendation to the Food and Drug Administration.

The central issue is how the company will make sure that the medicine intended to relieve the chronic pain of fibromyalgia patients doesn't find its way into the hands of creeps.

The FDA released a bunch of documents in advance of the hearing that describe the company's plans for safeguarding the supply. Essentially, only approved doctors would be allowed to prescribe the medicine. Patients' eligibility would be verified, and they'd be registered in a database. Then, according to the plan, one of 15 specially certified pharmacies would ship the stuff to them. No walk-up, retail prescriptions allowed.

Jazz already has some experience with these sorts of controls. It already sells GHB as Xyrem to treat narcolepsy. But a lot more people have fibromyalgia — an estimated 5 million — than have narcolepsy.

A preliminary report by FDA reviewers appeared to support the effectiveness of Rekinla for pain relief.

"Now it's a question of how do we go out there and control the dispensing of the drug," industry analyst Steve Brozak told Reuters. He was optimistic the agency would ultimately approve the application, saying "There's always a way to meet safeguards."

Update: The experts who met Friday voted 20-2 to recommend against FDA approval of Rekinla. Concerns about the adequacy of company's program to limit diversion of the medicine weighed heavily on panelists. The Street.com's Adam Feuerstein live-blogged the event, and you can see his blow-by-blow account here.

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