Jazz Pharmaceuticals plc said the U.S. Food and Drug Administration approved Sunosi as a treatment for a type of sleep disorder.
Sunosi, or or solriamfetol, is now approved to treat excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
Narcolepsy is a neurological disorder affecting control of sleep and wakefulness. It is characterized by excessive sleepiness and inability to regulate sleep-wake cycles normally. Obstructive sleep apnea is a disorder that causes breathing to repeatedly stop and start during sleep with excessive sleepiness as one of its major symptoms.
The FDA approval is based on data from a phase 3 clinical program called Tones, which included four studies showing Sunosi was better than placebo at treating the disease.
The drug is expected to be available in the U.S. after the U.S. Drug Enforcement Administration makes a final scheduling decision, usually within 90 days of FDA approval.
Dublin-based Jazz has also submitted an application to the European Medicines Agency seeking approval for solriamfetol in the same indications.
The Irish drugmaker, whose top-selling drug Xyrem also treats narcolepsy as well as cataplexy, acquired rights to develop and commercialize solriamfetol from Aerial BioPharma LLC in 2014.