Jazz Pharmaceuticals Submits Marketing Authorization Application to European Medicines Agency for Solriamfetol
Jazz Pharmaceuticals plc 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,” says 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, in a release. “Jazz is committed to addressing unmet needs in sleep medicine by delivering meaningful treatment options.”
Yves Dauvilliers, MD, PhD, head of sleep and wake Disorders at the University Hospital of Montpellier, France, says, “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. 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.”
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 with narcolepsy at the annual meeting of the Associated Professional Sleep Societies (APSS)/SLEEP in June 2018. TONES 2, 3, and 4 data were presented at APSS in 2017.
from Sleep Review http://www.sleepreviewmag.com/2018/11/marketing-authorization-application-solriamfetol/