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Jazz Pharma Submits MAA To European Medicines Agency For Solriamfetol

Jazz Pharmaceuticals plc (JAZZ) announced Friday the submission of a Marketing Authorization Application or MAA to the European Medicines Agency for solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor. It is for the treatment to improve wakefulness and reduce excessive daytime sleepiness or EDS in adult patients with narcolepsy (with or without cataplexy) or obstructive sleep apnea or OSA.

Jazz said it has studied solriamfetol extensively via the Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program, which was comprised of four studies.

Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment of EDS in adult patients with narcolepsy, OSA, and Parkinson's disease. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma.

Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan.

Solriamfetol has orphan drug designation in the United States for narcolepsy. In March 2018, Jazz announced that the U.S. Food and Drug Administration accepted for filing with standard review the company's New Drug Application or NDA seeking marketing approval for solriamfetol for the treatment of ES in adult patients with narcolepsy or OSA. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is December 20, 2018.

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