Axsome Therapeutics, a biopharmaceutical company developing therapies for the management of central nervous system (CNS) disorders, announced the completion of its U.S. acquisition of Sunosi® (solriamfetol) from Jazz Pharmaceuticals. Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). The ex-U.S. transaction is expected to close within 60 days.
Sunosi was approved by the U.S. Food and Drug Administration (FDA) in 2019 and by the European Medicines Agency (EMA) in 2020 based on data from randomized placebo-controlled studies in patients with EDS associated with narcolepsy or OSA that demonstrated the superiority of Sunosi relative to placebo.
Sunosi should not be used in patients who are taking, or have stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI). The most common adverse reactions (incidence ≥5% and higher than placebo) reported in both the narcolepsy and OSA study populations were headache, nausea, decreased appetite, and anxiety. Sunosi 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.
Although the exact mechanism of action is unknown, the effects of Sunosi are thought to be mediated through its activity as a DNRI. Sunosi is the first and only DNRI approved by the FDA to treat EDS in adults living with narcolepsy or OSA.