Jan 22, 2020:Jazz Pharmaceuticals reported that the European Commission endorsed Sunosi® (solriamfetol) to improve alertness and lessen unnecessary daytime languor (EDS) in grown-ups with narcolepsy (with or without cataplexy) or obstructive rest apnea (OSA) whose EDS has not been acceptably treated by essential OSA treatment, for example, ceaseless positive aviation route pressure (CPAP).
Mechanism of action: Sunosi is the primary double acting dopamine and norepinephrine reuptake inhibitor endorsed to treat EDS in grown-ups living with narcolepsy or OSA and the main authorized treatment in the European Union for the treatment of EDS in grown-ups living with OSA.
Sunosi is approved with doses of 75 mg and 150 mg once-daily for people with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for the patients with OSA.
At Week 12 of the Phase 3 clinical trial, 150 mg of solriamfetol for the narcolepsy patients and both 75 mg and 150 mg doses for OSA patients established improvements in restlessness compared to the placebo as assessed via the maintenance of wakefulness test from approximately one hour post-dose through around nine hours post-dose.
Solriamfetol has the potential to be an important treatment option for the patients living with extreme daytime sleepiness as a result of OSA or narcolepsy.
The Marketing Authorisation Application (MAA) for Sunosi is based on the facts from four randomised placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) clinical trial program.
Data from the studies in the TONES program established the superiority of solriamfetol relative to the placebo. The most commonly reported adverse reactions were headache (11.1%), nausea (6.6%) and decreased appetite (6.8%).
The most serious and frequently occurring adverse reactions were increased blood pressure and palpitations.
In the TONES 2 and TONES 3 12-week clinical studies in the narcolepsy and OSA patients, respectively, around 68-74% of people taking solriamfetol at the 75 mg dose and 78-90% of people taking solriamfetol at the 150 mg dose reported enhancement in their overall clinical condition, as assessed by the Patient Global Impression of Change (PGIc) scale. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-receives-eu-marketing-authorisation-sunosir
