US FDA panel says overwhelming 'no' to using Jazz Pharma's date-rape type drug for fibromyalgia

The Joint Advisory Committee of the US Food and Drug Administration, including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, on Friday voted 20 to two that the benefit/risk balance did not support the approval of JZP-6/sodium oxybate for the treatment of fibromyalgia with the currently proposed Risk Evaluation Mitigation Strategy (REMS).

California-based Jazz Pharmaceuticals (Nasdaq: JAZZ) was seeking approval to market the sodium oxybate product, which is deemed as being a pharmaceutical-grade form of gamma hydroxybutyrate (GBH), under the brand name Rekinla as a treatment for the pain disorder fibromyalgia. Jazz stock plunged 26% to $7.56 in extended trading on Friday following the news.

FDA briefing papers ahead of the advisory panel meeting indicated that, while the agency believes the drug is effective in treating the condition, it has reservations about GBH's links with malicious spiking of people's drinks, ie, it is used as a 'date-rape' drug. The company already sells the product as Xyrem for the treatment of narcolepsy, albeit under strict controls (Schedule III controlled substance), and the drug generated second-quarter sales of $33.7 million and $96.8 million for the whole of 2009.

"Sodium oxybate and GHB are the same thing," said panelist Lewis Nelson, MD, of the New York University School of Medicine, adding: "This is much better than the stuff you get on the street, and that is the problem."