Jazz Pharmaceuticals PLC is seeking the U.S. Food and Drug Administration's approval for Solriamfetol to treat excessive sleepiness in adults with narcolepsy or obstructive sleep apnea.
The company submitted a new drug application for the therapy supported by data from a number of phase 3 clinical trials.
Jazz acquired the rights to develop and commercialize the drug from Aerial BioPharma LLC in 2014.
Narcolepsy is a debilitating neurological disorder characterized by excessive sleepiness, and the inability to regulate sleep-wake cycles normally, while obstructive sleep apnea is a sleep disorder which causes breathing to repeatedly stop and start during sleep.
