Officials with the FDA have approved solriamfetol (Sunosi, Jazz Pharmaceuticals), a novel therapeutic option to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA), according to a press release.
 
Solriamfetol is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA for this indication. The drug is a once-daily treatment with 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.
 
Narcolepsy is a chronic neurological disorder that causes periods of excessive daytime sleepiness. Although the cause of the disease is not fully understood, individuals with narcolepsy typically have low levels of the naturally occurring chemical hypocretin, which promotes wakefulness and regulates REM sleep, according to the National Institute of Neurological Disorders and Stroke.
 
The approval is based on data from the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) phase 3 clinical trial program, which consisted of 4 studies evaluating approximately 900 adults.
 
Key data showed that 150 mg of solriamfetol for patients with narcolepsy and all doses for patients with OSA improved wakefulness at week 12 compared with placebo in test sessions of the maintenance wakefulness test approximately 1 to 9 hours post-dose. Additionally, solriamfetol maintained its effect relative to placebo after 6 months of use, according to the findings. Approximately 68% to 74% of patients taking solriamfetol at the 75 mg dose and 78% to 90% of patients taking solriamfetol at the 150 mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change scale.
 
Underlying airway obstruction should be treated, such as with continuous positive airway pressure (CPAP) for at least 1 month prior to initiating treatment with solriamfetol in patients with OSA, according to Jazz.
 
“Sunosi is an effective treatment option with a novel mechanism of action as a dual-acting dopamine and norepinephrine reuptake inhibitor,” Richard K Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine and chief medical officer at SleepMed, said in a statement. “Excessive daytime sleepiness is the most common symptom for people with narcolepsy and a major complaint of people with obstructive sleep apnea. In some people with obstructive sleep apnea, excessive daytime sleepiness may persist despite using CPAP.”
 
Jazz anticipates solriamfetol to be commercially available in the United States following the final scheduling decision by the US DEA, which is typically within 90 days of the approval, according to the release.
 
References
 
Jazz Pharmaceuticals Announces US FDA Approval of Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructuve Sleep Apnea [news release]. Jazz Pharmaceuticals. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-sunositm. Accessed March 21, 2019.
 
NIH. Narcolepsy Fact Sheet. National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Narcolepsy-Fact-Sheet. Accessed March 21, 2019.