European Commission approves Sunosi® (solriamfetol)

EU marketing authorisation has been given to Sunosi (solriamfetol) for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.

The European Commission (EC) has approved Sunosi® (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).

Sunosi, which is developed by Jazz Pharmaceuticals plc, 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.

“We are excited that with this approval we can offer Sunosi, a daytime medicine that can provide sustained wakefulness throughout the day, to patients living with excessive daytime sleepiness as a result of OSA or narcolepsy in Europe, where historically, treatment options have been very limited,” said Bruce Cozadd, Chairman and Chief executive officer of Jazz Pharmaceuticals.

Once-daily Sunosi is approved with doses of 75mg and 150mg for people with narcolepsy and doses of 37.5mg, 75mg and 150mg for patients with OSA.

At Week 12 of the Phase III clinical trial, 150mg of solriamfetol for narcolepsy patients and both 75mg and 150mg doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed via the maintenance of wakefulness test from approximately one hour post-dose through approximately nine hours post-dose, the company said.

“Most people feel tired sometimes, but those with excessive daytime sleepiness may experience an irresistible need to sleep during the day and an increased likelihood of falling asleep at unexpected times, which can interfere with work, school and other activities,” said Professor 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. “In the EU, approximately 16 million people may be affected by OSA to some extent, and some of them continue to experience excessive daytime sleepiness despite adequate treatment with CPAP for upper airway obstruction.

“Solriamfetol has the potential to be an important treatment option for patients living with excessive daytime sleepiness as a result of OSA or narcolepsy.”