EMA Panel Backs Solriamfetol (Sunosi) for Narcolepsy, OSA

Megan Brooks

November 15, 2019

A panel of the European Medicines Agency (EMA) has recommended solriamfetol (Sunosi, Jazz Pharmaceuticals) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure.

Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor.

The Committee for Medicinal Products for Human Use (CHMP) recommended once-daily solriamfetol at doses of 75 mg and 150 mg for people with narcolepsy and at doses of 37.5 mg, 75 mg, and 150 mg for people with OSA, the company said in a news release.

The CHMP decision is based on data from four randomized placebo-controlled studies that were 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 common side effects with solriamfetol are headache and nausea.

In March, the US Food and Drug Administration approved solriamfetol for improving wakefulness in adults with EDS associated with narcolepsy or OSA, as reported by Medscape Medical News.

Detailed recommendations for the use of solriamfetol will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

Solriamfetol should be prescribed by physicians experienced in the treatment of narcolepsy, the EMA said.

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