BRIDGEWATER, N.J. – Amneal Pharmaceuticals has announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem. Amneal had previously 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 in patients 7 years of age and older with narcolepsy. Narcolepsy is characterized by excessive daytime sleepiness, sudden sleep attacks, and cataplexy, a sudden loss of muscle control often triggered by emotions and sodium oxybate is considered a standard of care therapy in narcolepsy due to its ability to consolidate nighttime sleep and significantly reduce 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.”
The most common adverse reactions in adults taking sodium oxybate oral solution include nausea, dizziness, vomiting, somnolence, enuresis (bedwetting), and tremor. In pediatric patients the most common adverse events were nausea, enuresis, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking. Full prescribing information including boxed warning is available here.
