FDA Clears Solriamfetol (Sunosi) for Narcolepsy, OSA

Megan Brooks

March 21, 2019

The US Food and Drug Administration (FDA) has approved solriamfetol (Sunosi, Jazz Pharmaceuticals) to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

Solriamfetol is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA for this indication. Taken once daily by mouth, the drug is approved in doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg, and 150 mg for patients with OSA.

"Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home, or in daily activities. With this approval, a new daytime medicine that can provide sustained wakefulness throughout the day will be available for patients," Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in a news release.   

The approval of solriamfetol was based on data from the Treatment of Obstructive Sleep Apnea and Narcolepsy Excessive Sleepiness (TONES) phase 3 clinical program, which included four randomized placebo-controlled studies that demonstrated the superiority of solriamfetol relative to placebo.

Solriamfetol was evaluated in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or OSA and was shown to maintain its effect relative to placebo after 6 months of use.

At week 12, 150 mg of solriamfetol for patients with narcolepsy and all doses for patients with OSA demonstrated improvements in wakefulness compared with placebo as assessed at roughly 1 and 9 hours after dosing on the maintenance of wakefulness test.

In clinical studies, 68% to 74% of people taking solriamfetol at the 75-mg dose and 78% to 90% of those taking the 150-mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change scale.

The most common adverse reactions (incidence ≥ 5%) reported in both the narcolepsy and OSA study populations were headache, nausea, decreased appetite, and anxiety.

Solriamfetol is not intended to treat the underlying airway obstruction in OSA, which should be treated with continuous positive airway pressure for at least 1 month before starting the drug to address excessive daytime sleepiness in OSA, the company said. Modalities to treat the underlying airway obstruction should be continued during solriamfetol treatment.

Solriamfetol can be a target for people who abuse prescription medicines or street drugs. The company expects solriamfetol to be commercially available in the United States following the final scheduling decision by the Drug Enforcement Agency, which is typically within 90 days of approval.

Full prescribing information and medication guide is available online.

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