Solriamfetol is indicated to improve wakefulness in people with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnoea. Credit: Wokandapix / Pixabay.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Sunosi, discovered by SK Biopharmaceuticals, is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI). Jazz Pharmaceuticals licensed the drug from Aerial Biopharma in 2014.

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.

“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.”

During the studies, the most common adverse reactions were observed to be headache, nausea, decreased appetite and anxiety in both narcolepsy and OSA patients.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.