Posted by Michael Wonder on 10 Nov 2018
Jazz Pharmaceuticals submits marketing authorisation application to EMA for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnoea
9 November 2018 - Jazz Pharmaceuticals today announced the submission of a marketing authorisation application to the EMA for solriamfetol, a selective dopamine and norepinephrine re-uptake inhibitor, as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy) or obstructive sleep apnoea.
Jazz has studied solriamfetol extensively via the Treatment of Obstructive sleep apnoea (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 excessive daytime sleepiness in patients with narcolepsy or OSA (TONES 5).
