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Jazz Pharma's Sunosi becomes first EU-approved drug of its kind in narcolepsy and sleep apnoea

Published on 21/01/20 at 12:31pm

Jazz Pharmaceuticals has secured approval from the European Commission for Sunosi (solriamfetol), it has emerged, as a therapy to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) or narcolepsy with or without cataplexy.

The indication relates to patients whose EDS has not been effectively tackled by primary OSA therapy. It marks the first licensed dual-acting dopamine and norepinephrine reuptake inhibitor approved in Europe for this indication.

“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, 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.”

Data supporting the approval demonstrated the superiority of the therapy compared to placebo; 68-74% of patients taking 75mg Sunosi and 78-90% taking 150mg saw their overall clinical condition improve according to the Patient Global Impression of Change (PGIc) scale.

“Today's approval is an important milestone both for patients and for Jazz as we expand our neuroscience business to Europe to address unmet needs for people living with chronic, and often debilitating, sleep disorders," said Daniel Swisher, President and Chief Operating Officer of Jazz Pharmaceuticals. "Jazz is committed to making Sunosi available to patients in the EU and will now pursue rolling launches across the European Union on a country-by-country basis as pricing and reimbursement and scheduling decisions are made."

Matt Fellows

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