FDA Approves Generic Oral Treatment for Narcolepsy

The FDA has approved the first generic version of Xyrem (sodium oxybate) oral solution for patients with narcolepsy under strict safety requirements. The drug is indicated to treat cataplexy and excessive daytime sleepiness attributed to narcolepsy, which can cause potentially debilitating symptoms such as loss of muscle control or muscle weakness.

Xyrem and its generic version are required to adhere to strict safety control on prescribing and dispensing under the Risk Evaluation and Mitigation Strategy (REMS) program due to potentially serious risks. Xyrem has been associated with adverse effects such as seizures, trouble breathing, changes in alertness, coma, and death. Both medications contain the active ingredient sodium oxybate, which is the sodium salt of gamma hydroxybutyrate (GHB). GHB has not been approved for medical use and has the potential for abuse.

Under the REMS, Xyrem and its generic version must be prescribed by a certified prescriber, and dispensed through a certified pharmacy that ships directly to patients. Sodium oxybate will not be available in retail pharmacies.

Reference

FDA approves a generic of Xyrem with a REMS Program [news release]. Silver Spring, MD. FDA website. http://www.fda.gov/Drugs/DrugSafety/ucm537281.htm. Accessed Jan. 19, 2017.