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Jazz Pharmaceuticals Receives EU Marketing Authorisation for Sunosi® (solriamfetol) for Excessive Daytime Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea
Excessive daytime sleepiness is a major symptom in people with obstructive sleep apnea that persists in some patients despite use of continuous positive
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"Excessive daytime sleepiness is a major symptom in people with obstructive sleep apnea that persists in some patients despite use of continuous positive airway pressure\n Sunosi is the only licensed therapy in Europe for the treatment of excessive daytime sleepiness in adults living with obstructive sleep apnea\n\n\nDUBLIN, Jan. 20, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission 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).1 Sunosi 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 European Union for the treatment of EDS in adults living with OSA.\n\"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. \nOnce-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.1 At Week 12 of the Phase 3 clinical trial, 150 mg of solriamfetol for narcolepsy patients and both 75 mg and 150 mg 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.\n\"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, M.D., Ph.D., 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 b...