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EU marketing authorisation for Sunosi for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea


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 obstructive sleep apnea ( OSA ) whose excessive daytime sleepiness has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure ( CPAP ).

Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat excessive daytime sleepiness in adults living with narcolepsy or obstructive sleep apnea and the only licensed therapy in the European Union for the treatment of excessive daytime sleepiness in adults living with obstructive sleep apnea.

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 obstructive sleep apnea.

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 patients with obstructive sleep apnea has 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.

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 have 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 excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea 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 patients with obstructive sleep apnea, 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 obstructive sleep apnea. 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 obstructive sleep apnea.

Obstructive sleep apnea, commonly referred to as sleep apnea, is a highly prevalent disease affecting approximately 16 million people in the EU to some extent. Excessive daytime sleepiness, a major symptom of obstructive sleep apnea, is characterized by the inability to stay awake and alert during the day resulting in unplanned lapses into sleep or drowsiness. Positive airway pressure therapy, with its most common form being continuous positive airway pressure ( CPAP ), has been shown to be an effective therapy for sleep apnea that frequently results in improvement in excessive daytime sleepiness in many patients; however, not all patients tolerate CPAP therapy and among those who tolerate CPAP, usage is highly variable. Excessive daytime sleepiness may persist in people with obstructive sleep apnea despite using CPAP.

Narcolepsy is a chronic, debilitating neurological disorder characterized by excessive daytime sleepiness, and the inability to regulate sleep-wake cycles normally. Narcolepsy is a rare disease with an estimated prevalence of 0.02% in European populations. Studies have shown it may take 10 years or more for people with narcolepsy to receive a diagnosis, and it is estimated that more than 50% of patients with narcolepsy have not been diagnosed. There are five primary symptoms of narcolepsy, including excessive daytime sleepiness, cataplexy, sleep-related hallucinations, sleep paralysis and sleep disruption. While all patients with narcolepsy experience excessive daytime sleepiness, they may not experience all five symptoms. ( Xagena )

Source: Jazz Pharmaceuticals, 2020

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