Jazz Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
Sunosi is a first-in-class dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI). The approval was supported by data from the phase 3 TONES (Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness) program, which included 4 randomized placebo-controlled studies. In the studies, treatment with Sunosi demonstrated superiority over placebo. Over 900 adults with excessive daytime sleepiness associated with narcolepsy or OSA have been evaluated.
At week 12, the Sunosi 150mg dose in narcolepsy patients and all doses in OSA patients led to improvements in wakefulness vs placebo as seen in test sessions approximately 1 to 9 hours post-dose of the maintenance of wakefulness test (MWT). Patients taking Sunosi 75mg and 150mg doses also exhibited improvement in their overall clinical condition at week 12, as measured by the Patient Global Impression Change (PGIc) scale. Moreover, the clinical effect of Sunosi was maintained compared with placebo after 6 months of use.
Headache, nausea, decreased appetite, and anxiety were the most common adverse reactions reported in the narcolepsy and OSA patient populations.
As Sunosi is not indicated to treat the underlying airway obstruction in OSA, patients should receive OSA therapy (e.g., with continuous positive airway pressure [CPAP]) for at least 1 month prior to initiating Sunosi for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with Sunosi.
Sunosi will be available as 75mg (functionally scored) and 150mg tablets in 30- and 100-count bottles following final scheduling by the Drug Enforcement Administration (DEA), which usually occurs within 90 days of FDA approval.
For more information call (800) 520-5568 or visit Jazzpharmaceuticals.com.