Xyrem Oral Solution Generic Approved With REMS Program
FDA approves first generic version of Xyrem (sodium oxybate) Oral Solution for the treatment of cataplexy and daytime sleepiness in patient with narcolepsy.
The first generic formulation of Xyrem (sodium oxybate) Oral Solution has been approved by the FDA for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy, according to a press release.
Cataplexy is the main symptom of narcolepsy, causing sudden muscle tone loss while awake, including voluntary muscle control. Cataplexy affects approximately 70% of individuals with narcolepsy. Sodium oxybate is currently the only medication approved to treat cataplexy in patients with narcolepsy.
Xyrem is associated with serious adverse events, including difficulty breathing, changes in alertness, seizures, coma, and death, according to the release. The active ingredient in Xyrem and the generic is sodium oxybate—–the sodium salt of gamma hydroxybutyrate (GHB).
GHB is not approved for medical use and has the potential for abuse, such as in cases of sexual assault, the release stated.
The risks associated with Xyrem means it is subject to strict safety controls on prescribing and dispensing under the Risk Evaluation Mitigation Strategy (REMS) program. According to the release, the FDA’s approval of generic sodium oxybate is subject to a REMS, with strict safety controls comparable to those currently required for Xyrem.
Under the Xyrem REMS and the generic sodium oxybate REMS, sodium oxybate can only be prescribed by a certified prescriber, and only dispensed to patients enrolled by a certified pharmacy, according to the release.
Sodium oxybate will not be available in retail pharmacies, and only a certified pharmacy that ships directly to patients will be allowed to dispense it.