The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorization of Jazz Pharmaceuticals’ 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.
“Today’s positive CHMP opinion is an important milestone for people living with EDS associated with narcolepsy or OSA, which has been shown to negatively impact the lives of people living with these conditions,” says Robert Iannone, MD, MSCE, executive vice president, research and development of Jazz Pharmaceuticals, in a release. “This milestone brings us one step closer to potentially providing a new treatment option for people living with these sleep disorders in Europe.”
The Marketing Authorisation Application (MAA) for solriamfetol is based on data from four randomized 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,” says Jean-Louis Pépin, MD, PhD, 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.”
Jazz Pharmaceuticals filed the MAA for solriamfetol with the EMA in November 2018. The positive opinion from the CHMP will now be reviewed by the European Commission, which has the authority to approve medicines in all European Union Member States, Iceland, Norway, and Liechtenstein. A decision from the European Commission is expected within 67 days of receiving the CHMP opinion.