FDA Approves Generic Version of Narcolepsy Drug Xyrem with REMS

The FDA approved the first generic version of Xyrem (sodium oxybate) oral solution, to treat patients with narcolepsy.

The generic is also approved to treat cataplexy, a condition in which patients suddenly lose muscle tone and control while awake, which can them to collapse. Xyrem, originally developed by Jazz Pharmaceuticals, is the only medication approved to treat cataplexy in patients with narcolepsy. The generic is produced by Roxane Laboratories.

FDA’s approval of generic sodium oxybate is subject to a Risk Evaluation and Mitigation Strategy with strict safety controls on prescribing and dispensing comparable to those currently required for Xyrem, which has been associated with adverse events including seizures, trouble breathing, coma and death.

Sodium oxybate is the sodium salt of gamma hydroxybutyrate, known as the sexual assault drug GHB. Sodium oxybate can be prescribed only by a certified prescriber, and dispensed only to an enrolled patient by a certified pharmacy.