Jazz Pharmaceuticals' Xyrem for Fibromyalgia - Can this notorious drug find redemption in fibromyalgia?

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GHB is a powerful nervous system depressant that gained notoriety in the 1990s as a "date rape" drug. Despite its reputation and schedule I restriction, FDA approved a branded GHB formulation, Xyrem, for treating narcolepsy. In 2009, Xyrem sales accounted for about $97 million in revenues for Jazz Pharmaceuticals, which is now seeking to expand the market opportunity for Xyrem into fibromyalgia, a much more prevalent condition. This report reviews the phase III results, the safety and efficacy, and risk/benefit of Xyrem in fibromyalgia, as well as its complex history and track record in other settings, as a means to gauge the likelihood of FDA approval in the Fall.

Published: June 10th, 2010

Number of pages: 20

Authors: Dr. Drew Applefield and Dr. Ellen Brady

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