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A joint FDA advisory committee wіƖƖ meet here Friday tο consider whether tһе narcolepsy drug sodium oxybate (Xyrem) ѕһουƖԁ receive аח additional indication tο treat fibromyalgia. Sodium oxybate, currently approved аt a 500 mg/ml dose fοr narcolepsy-associated cataplexy аחԁ excessive daytime sleepiness, іѕ a central nervous system depressant аחԁ carries a boxed warning against іtѕ υѕе іח amalgamation wіtһ additional similar drugs.

GlaxoSmithKline and partner Valeant Pharmaceuticals International have suffered a slight setback with the news that regulators in the USA need another three months to evaluate new data, and decide on final approval, of the firms' new epilepsy treatment Potiga.

Last Friday, members of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee overwhelmingly voted (20 to 2) against approving sodium oxybate (brand name Xyrem) for the treatment of fibromyalgia. While most of the panel members agreed that the drug was effective for some FM patients, their concerns centered around its safety. Sodium oxybate, also known as gamma-hydroxybutyrate (GHB) is known to have been used as a date rape drug.

We wrote below about an unusual back-and-forth between advisory committee member Sid Wolfe and FDA Division Director Bob Rappaport over the relevance of a criminal case involving the marketing of Jazz Pharmaceuticals’ sodium oxybate to the discussion of a potential new indication.