Dublin-based Jazz Pharmaceuticals PLC said that the European Commission approved Sunosi to treat a type of sleep disorder.
Sunosi, or solriamfetol, has been granted approval for the treatment of excessive daytime sleepiness, or EDS, associated with narcolepsy or obstructive sleep apnea, or OSA, for patients whose EDS has not been satisfactorily treated by primary OSA therapy.
Narcolepsy is a neurological disorder that affects the control of sleep and wakefulness. Patients experience excessive sleepiness and inability to regulate sleep-wake cycles normally. OSA is a disorder that causes breathing to repeatedly stop and start during sleep with excessive sleepiness as one of its major symptoms.
The EC's approval is based on data from a four-study program called Tones, which showed the medication to be superior to placebo in treating the disease.
The U.S. Food and Drug Administration approved Sunosi for the same indication in March 2019.