The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorisation of solriamfetol to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy.
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 CHMP recommended that once daily solriamfetol be approved with doses of 75 mg and 150 mg for people with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for people with OSA.
Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or OSA. Solriamfetol, marketed as Sunosi in the US, received US FDA approval on March 20, 2019 to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the US Drug Enforcement Agency (DEA)
In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC.