The FDA has approved a generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy.
The generic version is developed by Roxane Laboratories Inc. The original Xyrem is an orphan drug marketed by Jazz Pharmaceuticals that was first approved in 2002.
Cataplexy is common in patients with narcolepsy in which they suddenly lose muscle tone, including voluntary muscle control, while awake. Approximately 70% of people with narcolepsy have cataplexy. Xyrem is the only medication approved to treat cataplexy in patients with narcolepsy.
Safety Still a Concern
According to the FDA, Xyrem comes with some serious side effects including seizures, trouble breathing, changes in alertness, coma, and death. In addition, the active ingredient in Xyrem, sodium oxybate, is the sodium salt of gamma hydroxybutyrate (GHB). GHB has the potential for abuse, such as in cases of sexual assault.
Due to these safety concerns, FDA’s approval of generic Xyrem is subject to a Risk Evaluation and Mitigation Strategy (REMS) with strict safety controls.
Narcolepsy is a chronic brain disorder that involves poor control of sleep-wake cycles. People with narcolepsy experience periods of extreme daytime sleepiness and sudden, irresistible bouts of sleep that can strike at any time. These “sleep attacks” usually last a few seconds to several minutes.
Narcolepsy can greatly affect daily activities. People may unwillingly fall asleep while at work or at school, when having a conversation, playing a game, eating a meal, or, most dangerously, when driving or operating other types of machinery.
Xyrem markedly reduces cataplexy and is also effective in treating excessive daytime sleepiness in narcolepsy and it is considered an important therapy for those patients.
Thanks to the Rare Disease Report for this story.