DUBLIN—Jazz Pharmaceuticals plc received word today that the European Commission has approved Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy), or in adults with obstructive sleep apnea (OSA) who have not reacted satisfactorily to primary OSA therapy like continuous positive airway pressure (CPAP). The European Commission approval extends to all European Union member states, as well as Iceland, Norway and Liechtenstein.
“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.”
Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with EDS due to narcolepsy or OSA. It’s the only licensed therapy in the European Union for the treatment of EDS in adults living with OSA. Sunosi received U.S. Food and Drug Administration approval on March 20, 2019, and it was designated as a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. Once-daily Sunosi is 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 patients 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,” added Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.
The Marketing Authorisation Application (MAA) for Sunosi 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 most frequently reported adverse reactions were headache (11.1%), nausea (6.6%) and decreased appetite (6.8%). The most serious and frequently occurring adverse reactions were increased blood pressure and palpitations. The majority of most frequently reported adverse events occurred within the first two weeks of treatment and resolved for most patients within 2 weeks. Solriamfetol was evaluated in more than 900 adults with EDS associated with narcolepsy or OSA, and was shown to maintain its effect relative to placebo after six months of use.
In the TONES 2 and TONES 3 12-week clinical studies in narcolepsy and OSA patients, respectively, approximately 68-74% of people taking solriamfetol at the 75 mg dose and 78-90% of people taking solriamfetol at the 150 mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change (PGIc) scale.
“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. 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,” noted said Professor Jean-Louis Pépin, M.D., Ph.D., director of INSERM unit 1042 and head of the sleep and physiology department at the Centre Hospitalier Universitaire de Grenoble in France. “Solriamfetol has the potential to be an important treatment option for patients living with excessive daytime sleepiness as a result of OSA or narcolepsy.”