Axsome Therapeutics Inc, a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, has completed its US 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-US transaction is expected to close within 60 days.
“Excessive daytime sleepiness is one of the main presenting symptoms of obstructive sleep apnea, persists in 12% to 65% of individuals receiving CPAP therapy, and is the most common symptom in narcolepsy,” says Andrew Krystal, MD, professor of psychiatry and neurology at UCSF Weill Institute for Neurosciences, and vice-chair for research in the department of psychiatry, in a release. “Sunosi has a novel mechanism of action as a dual-acting dopamine and norepinephrine reuptake inhibitor, and has demonstrated significant efficacy relative to placebo for reducing excessive sleepiness and increasing wakefulness in clinical trials of narcolepsy and obstructive sleep apnea.”
Richard K. Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine in Columbia, SC, and associate clinical professor at Medical University of South Carolina in Charleston, SC, says in a release, “In several clinical trials, Sunosi has demonstrated significant efficacy in both subjective and objective measures of sleepiness in adults with narcolepsy and obstructive sleep apnea, with large effect sizes. Sunosi is an important treatment for patients living with these conditions. The effect of excessive daytime sleepiness on individuals with narcolepsy and obstructive sleep apnea includes functional impairment, reduced quality of life, and increased risk for occupational and motor vehicle accidents.”
Sunosi was approved by the US 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. 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.
Sunosi does not treat the underlying cause of airway obstruction in people with OSA and does not take the place of using a CPAP machine or other devices for the treatment of OSA. It is important to continue to use these treatments during treatment with Sunosi.
“We are proud to provide narcolepsy and obstructive sleep apnea patients with excessive daytime sleepiness continued access to Sunosi, and we intend to further research of this important medicine in other clinical settings,” says Herriot Tabuteau, MD, CEO of Axsome, in a release. “The Sunosi acquisition marks the transformation of Axsome into a commercial neuroscience company and reflects our commitment to the millions of people living with serious neurologic and psychiatric conditions.”
According to Axsome, the commercial insurance coverage for Sunosi currently totals 96% of commercial lives or approximately 253 million lives across all channels. Also, Axsome offers a patient affordability program that reduces barriers to access for appropriate patients.