EC Has Approved Solriamfetol

| By | Jazz Pharmaceuticals

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.

GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.