CHMP positive for solriamfetol to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea .- Jazz Pharma

Jazz Pharmaceuticals plc announced that 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 (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

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 program. Data from the studies in the TONES program 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. "Excessive daytime sleepiness due to narcolepsy or OSA may have negative impacts on a person's ability to function at work or at home, and in OSA patients EDS can still occur despite the compliant use of CPAP treatment for upper airway obstruction," said Professor Jean-Louis P�pin, M.D., Ph.D., Director of INSERM unit 1042 and head of the sleep and physiology department at the University Hospital in Grenoble, France. "I am hopeful this positive CHMP opinion leads to this novel treatment option becoming available for people living with EDS as a result of narcolepsy or OSA."