Solriamfetol Receives Schedule IV Designation for Excessive Daytime Sleepiness in Narcolepsy, Obstructive Sleep Apnea

June 17, 2019

Solriamfetol (Sunosi, Jazz Pharmaceuticals) is expected to be available in July 2019 in the United States.

Bruce Cozadd, MBA

Jazz Pharmaceuticals’ solriamfetol (Sunosi), an FDA-approved therapy indicated to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, has been designated as a Schedule IV medication by the US Drug Enforcement Agency (DEA).

Solriamfetol, the first and only FDA-approved dual-acting dopamine and norepinephrine reuptake inhibitor, will be commercially available in the United States in once-daily 75 mg and 150 mg tablets in July 2019.

“Jazz Pharmaceuticals focuses on doing what is best for patients and we are committed to the safe and appropriate use of our medicines for debilitating conditions like excessive daytime sleepiness associated with narcolepsy or OSA,” Bruce Cozadd, MBA, chairman, chief executive officer, Jazz Pharamceuticals, said in a statement.1 “We are pleased that Sunosi has received a Schedule IV designation that aligns with our research demonstrating this medicine’s relatively low potential for abuse and risk of dependence.”

The FDA approved solriamfetol in March 2019 based on the safety and efficacy data established in the TONES clinical trial program, which consisted of 4 phase 3 clinical trials. In the first study, TONES 2, solriamfetol was explored in narcolepsy, while TONES 3 and 4 examined the therapy in obstructive sleep apnea. TONES 5 investigated maintenance treatment in obstructive sleep apnea and narcolepsy.

Results from the clinical trial program showed a statistically significant change in the Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test in study participants with narcolepsy who received 300 mg or 150 mg solriamfetol versus placebo (P <.0001) or participants with obstructive sleep apnea who received 37.5 mg, 75 mg, 150 mg, or 300 mg doses (P <.05).2

The most commonly reportedly adverse events reported in both study populations, with an incidence ≥5% and higher than in placebo, were headache, nausea, decreased appetite, and anxiety. Notably, no serious adverse events were recorded.

"Excessive daytime sleepiness can have a significant impact on the lives of people with narcolepsy or OSA. With this scheduling decision, we move closer to commercial availability of Sunosi, which can improve wakefulness throughout the day in these patients," Daniel Swisher, president and chief operating officer of Jazz Pharmaceuticals, said in a statement.1 "Sunosi is the first medicine that Jazz has taken through phase 3 development to commercialization, further evidence of the success of our growing research and development capabilities.”

Solriamfetol is not indicated to treat the underlying airway obstruction associated with obstructive sleep apnea. Patients with obstructive sleep apnea should be treated with continuous positive airway pressure for at least 1 month prior to initiating treatment with solriamfetol and should be continued throughout treatment with solriamfetol. Solriamfetol is contraindicated in patients currently taking or who have recently stopped taking monoamine oxidase inhibitors for depression. Patients who take solriamfetol while pregnant are encouraged to participate in the pregnancy registry.

REFERENCES

1. Jazz Pharmaceuticals Receives Schedule IV Designation from DEA for Sunosi™ (solriamfetol) [news release]. Dublin: Jazz Pharmaceuticals; June 17, 2019. https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-receives-schedule-iv-designation-from-dea-for-sunosi-solriamfetol-300869335.html. Accessed June 17, 2019.

2. Jazz Pharmaceuticals annouces US FDA approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea [news release]. Dublin, Ireland: Jazz Pharmaceuticals; March 20, 2019. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-sunositm. Accessed June 17, 2019.