US-based Amneal Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its sodium oxybate oral solution 500mg/mL.
The sodium oxybate oral solution is prescribed for managing cataplexy and excessive daytime sleepiness (EDS) in individuals with narcolepsy.
Narcolepsy is characterised by excessive daytime drowsiness, sudden sleep episodes, and cataplexy, a sudden loss of muscle tone triggered by emotions.
The US regulatory agency approved the company’s abbreviated new drug application (ANDA) for sodium oxybate, which references Jazz Pharmaceuticals’ Xyrem.
Before the FDA approval, the US drugmaker had been distributing a limited quantity of an authorised generic version of sodium oxybate oral solution.
The approval expands its affordable medicines portfolio, said Amneal.
Amneal retail affordable medicines senior vice president Tony Rosa said: “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 US.
“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.”
Sodium oxybate is used as a standard treatment for narcolepsy based on its potential to improve nighttime sleep consolidation and reduce cataplexy episodes.
Common side effects of the sodium oxybate oral solution in adults include nausea, dizziness, vomiting, somnolence, enuresis (bedwetting), and tremors.
In children, the most frequently reported adverse effects are nausea, enuresis, vomiting, headache, weight loss, decreased appetite, dizziness, and sleepwalking.
Based in Bridgewater, New Jersey, Amneal is a global biopharmaceutical entity with over 280 pharmaceuticals primarily distributed within the US.
The company’s Affordable Medicines segment is focused on a wide range of complex product categories, including injectables and biosimilars.
Earlier this year, Amneal received FDA approval for Brekiya, an autoinjector containing dihydroergotamine (DHE) mesylate, to treat acute migraines in adults.
Brekiya, designed for self-administration without the need for refrigeration, priming, or assembly, is the first DHE autoinjector approved for migraines with or without aura and cluster headaches in the adult population.
