The US Food and Drug Administration (FDA) has approved Ireland-based Jazz Pharmaceuticals ’ Sunosi (solriamfetol) drug to treat adults suffering from excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA).
Once-daily 75mg and 150mg doses of the drug can be used to improve wakefulness in narcolepsy patients, while 37.5mg, 75mg and 150mg doses are indicated for OSA.
The US regulatory approval of the drug is based on results from the Phase III clinical programme involving four randomised, placebo-controlled studies.
All trials, which enrolled a total of 900 adults with excessive daytime sleepiness associated with narcolepsy or OSA, showed superiority of Sunosi compared to placebo.
During the studies, the most common adverse reactions were observed to be headache, nausea, decreased appetite and anxiety in both narcolepsy and OSA patients.
The company noted that at week 12, 150mg of the drug for narcolepsy patients and all doses in OSA patients led to improvements in wakefulness, compared to placebo, at about one hour after dosing and around nine hours post-dose.
Data showed that approximately 68-74% of participants administered with the 75mg dose and 78-90% of those taking the 150mg dose experienced improvement in their overall clinical condition.
Jazz Pharmaceuticals chairman and CEO Bruce Cozadd said: “Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnoea 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.”
Sunosi is expected to be commercially launched in the US over the coming months.
Jazz Pharmaceuticals holds global development, manufacturing and commercialisation rights to Sunosi, except certain regions in Asia. SK Biopharmaceuticals has rights in 12 Asian markets.