Jazz Pharmaceuticals submits MAA to the EMA for solriamfetol

DUBLIN—Today, Jazz Pharmaceuticals plc has announced the submission of 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 Jed Black, MD, senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine. “Jazz is committed to addressing unmet needs in sleep medicine by delivering meaningful treatment options.”

Jazz has studied solriamfetol extensively via the Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program, which was comprised of four studies that evaluated solriamfetol in EDS in adult patients with narcolepsy (TONES 2) or OSA (TONES 3 and TONES 4), and the long-term safety and maintenance of efficacy for solriamfetol as a treatment for EDS in patients with narcolepsy or OSA (TONES 5).

Jazz presented long-term safety and maintenance of efficacy results from the TONES 5 Phase 3 study of solriamfetol in adult patients with EDS associated with OSA or narcolepsy at the annual meeting of the Associated Professional Sleep Societies (APSS) in June 2018. TONES 2, 3 and 4 data were presented at APSS in 2017.

“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,” mentioned Professor Yves Dauvilliers, MD, PhD, Head of Sleep and Wake Disorders at the University Hospital of Montpellier, France. “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.”

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 US Food and Drug Administration (FDA) accepted for filing with standard review the company’s New Drug Application seeking marketing approval for solriamfetol for the treatment of EDS in adult patients with narcolepsy or OSA. The Prescription Drug User Fee Act goal date for an FDA decision is December 20, 2018.