Jazz Pharmaceuticals Receives EU Marketing Authorisation for Sunosi® (solriamfetol) for Excessive Daytime Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea
"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
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.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.
"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
"Today's approval is an important milestone both for patients and for Jazz as we expand our neuroscience business to
The Marketing Authorisation Application (MAA) for Sunosi is based on data from four randomised 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.2-5 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
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.
Solriamfetol is not a therapy for the underlying airway obstruction in patients with OSA. Primary OSA therapy should be maintained in these patients and treatment should be initiated by a healthcare professional experienced in the treatment of narcolepsy or OSA.
For a full list of side effects and information on dosage and administration, contraindications and other precautions when using solriamfetol, please refer to the Summary of Product Characteristics for further information.
About Sunosi® (solriamfetol)
Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (
About Obstructive Sleep Apnea and Excessive Daytime Sleepiness
Obstructive sleep apnea (OSA), commonly referred to as sleep apnea, is a highly prevalent disease affecting approximately 16 million people in the EU* to some extent.10 Excessive daytime sleepiness (
Narcolepsy is a chronic, debilitating neurological disorder characterized by excessive daytime sleepiness (
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* This figure represents OSA prevalence in the EU5, including
- European Medicines Agency Summary of Product Characteristics (SmPC). Sunosi.
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