The approval allows Amneal to offer a generic alternative for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy patients, expanding access to this standard of care therapy.
Key takeaways:
- Amneal Pharmaceuticals received FDA approval for its sodium oxybate oral solution 500 mg/mL, an Abbreviated New Drug Application referencing Jazz Pharmaceuticals’ Xyrem.
- The therapy is indicated for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy.
- Amneal previously distributed an authorized generic in limited quantities; this approval expands its Affordable Medicines portfolio.
- Common adverse reactions include nausea, dizziness, vomiting, and somnolence in adults, with similar side effects plus weight decrease and headache observed in pediatric patients.
The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals Inc’s Abbreviated New Drug Application (ANDA) for sodium oxybate oral solution 500 mg/mL.
The newly approved product references Jazz Pharmaceuticals’ Xyrem. Before this approval, Amneal had been distributing an authorized generic of sodium oxybate oral solution in limited quantities.
Sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. Considered a standard of care therapy for this condition, sodium oxybate helps consolidate nighttime sleep and significantly reduce cataplexy episodes—sudden loss of muscle control often triggered by emotions.
“This approval expands Amneal’s Affordable Medicines portfolio into a critical therapy area for patients living with narcolepsy, a rare neurological condition that affects approximately 150,000 individuals in the United States,” says Tony Rosa, senior vice president, retail affordable medicines, in a release. “By offering sodium oxybate, Amneal is providing patients, providers, and payers with a more affordable alternative in a therapeutic category that has historically been limited to a single manufacturer.”
According to the prescribing information, the most common adverse reactions observed in adults taking sodium oxybate oral solution include nausea, dizziness, vomiting, somnolence, enuresis, and tremor. In pediatric patients, the most common adverse events reported were nausea, enuresis, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking.
Headquartered in Bridgewater, NJ, Amneal Pharmaceuticals focuses on developing and distributing a diverse portfolio of pharmaceuticals, including complex product categories such as injectables and biosimilars within its Affordable Medicines segment.
