Amneal Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA). The application references Jazz Pharmaceuticals’ Xyrem®. Amneal sodium oxybate approval comes as Amneal has previously distributed an authorized generic of the same drug in limited quantities.
Sodium oxybate oral solution is a depressant for the central nervous system used in patients with narcolepsy who have either cataplexy or excessive daytime sleepiness (EDS). Narcolepsy is a neurological condition that commonly manifests with features of sudden sleep attacks, excessive daytime sleepiness, and cataplexy, which is an abrupt loss of muscle control often triggered by emotions. Within neurology, sodium oxybate is widely regarded as a standard therapy because of its effectiveness in consolidating nighttime sleep and its ability to reduce the frequency of cataplexy episodes.
“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,” said Tony Rosa, Senior Vice President, Retail Affordable Medicines. “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.”
Adverse reactions associated with sodium oxybate oral solution vary between adult and pediatric patients. In adults, the most commonly reported side effects include nausea, dizziness, vomiting, somnolence, enuresis (bedwetting), and tremor. Among pediatric patients, common reactions include nausea, vomiting, enuresis, headache, decreased weight, reduced appetite, dizziness, and sleepwalking.
