The US Food and Drug Administration (FDA) has approved Orzeyful (oveporexton) for the treatment of adults with narcolepsy type 1
Narcolepsy is a chronic neurological disorder characterized by an inability of the brain to control sleep-wake cycles. Patients with narcolepsy typically enter REM sleep more quickly, causing the boundaries between wakefulness and sleep to blur. This causes fragmented sleep at night as well as muscle weakness and dream activity while awake. Common symptoms include excessive daytime sleepiness, cataplexy, sleep paralysis, and hallucinations.
ORZEYFUL (oveporexton) is an oral orexin receptor 2 (OX2R) agonist designed to selectively stimulate the OX2R to restore signaling and address the underlying orexin deficiency associated with narcolepsy type 1.
The approval is based on results from the phase 3 FirstLight (NCT06470828) and RadiantLight (NCT06505031) studies that showed oveporexton significantly improves symptoms across the full range of the disease. These included improvements in excessive daytime sleepiness, cataplexy and health-related quality of life. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies. The most common side effects include insomnia, urinary urgency, urinary frequency and excessive saliva. Learn more about the results here.
The controlled substance classification for oveporexton is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days. After the classification is determined, the treatment will likely be available through a specialty pharmacy.
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To learn more about narcolepsy and other rare neurological disorders, visit https://checkrare.com/diseases/neurology-nervous-system-diseases/