Generic Narcolepsy Drug Approved with Strict Safety Controls

Generic Narcolepsy Drug Approved with Strict Safety Controls

The Food and Drug Administration (FDA) has approved Sodium Oxybate Oral Solution, the first generic version of Jazz’s Xyrem Oral Solution.

Xyrem, an antinarcoleptic (CNS depressant), is indicated to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy. Xyrem is currently the only treatment approved to treat cataplexy in patients with narcolepsy.

Serious adverse effects including seizures, trouble breathing, changes in alertness, coma, and death have been associated with the use of Xyrem. Sodium oxybate, the active ingredient, is the sodium salt of gamma hydroxybutyrate (GHB) and is not approved for any medical use. It has the potential for abuse in cases such as sexual assault.

Due to the potential risks, the prescribing and dispensing of Xyrem is under a Risk Evaluation and Mitigation Strategy (REMS) program. The program’s safety controls for Sodium Oxybate Oral Solution are comparable to those of brand Xyrem Oral Solution. Both the Xyrem REMS and Sodium Oxybate REMS programs state that they can be prescribed only by a certified prescriber and dispensed only to an enrolled patient by a certified pharmacy. Sodium Oxybate will not be available in retail pharmacies and only a certified pharmacy that mails directly to patients can dispense this drug.

Xyrem, a CIII controlled substance, is currently available in a 500mg/mL strength solution.