Solriamfetol to treat daytime sleepiness in EUMarch 6, 2020
The European Commission approved solriamfetol to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA).
Solriamfetol is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat EDS in adults living with narcolepsy or OSA and the only licensed therapy in the EU for the treatment of EDS in adults living with OSA.
The Marketing Authorisation Application (MAA) for solriamfetol is based on data from four randomised placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) clinical trial programme.
Data from the studies in the TONES programme demonstrated the superiority of solriamfetol relative to placebo. The most frequently reported adverse reactions were headache (11.1%), nausea (6.6%) and decreased appetite (6.8%).
Solriamfetol was evaluated in more than 900 adults with EDS associated with narcolepsy or OSA and was shown to maintain its effect relative to placebo after six months of use.