Jazz Pharma files for EMA approval of solriamfetol

Ireland-headquartered Jazz Pharmaceuticals (Nasdaq: JAZZ) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor, as a treatment to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA).

"Excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea can be debilitating for patients and challenging for the medical community to diagnose and treat," said Dr Jed Black, senior vice president, sleep and CNS medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine.

"In the European Union, there is no approved treatment for people with excessive daytime sleepiness associated with obstructive sleep apnea, and people with excessive daytime sleepiness due to narcolepsy may benefit from the availability of new treatment options," commented Professor Yves Dauvilliers, head of Sleep and Wake Disorders at the University Hospital of Montpellier, France, adding: "As the sleep medical community improves its understanding and diagnosis of these conditions, it is increasingly important that patients have multiple treatment options available to help them manage their condition more effectively."