The U.S. Drug Enforcement Agency (DEA) has designated Jazz Pharmaceuticals plc’s solriamfetol, also known as Sunosi, as a Schedule IV medicine, which is its category for drugs with a low potential for abuse and low risk of dependence.
With U.S. Food and Drug Administration approval on March 20, 2019, Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
“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,” says Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals, in a release. “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.”
Beginning early July, once-daily Sunosi will be commercially available in the United States in 75 mg and 150 mg tablets.
“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,” says Daniel Swisher, president and chief operating officer of Jazz Pharmaceuticals. “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.
Sunosi is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (such as with continuous positive airway pressure) for at least one month prior to initiating Sunosi. Sunosi is not a substitute for these modalities, and the treatment of the underlying airway obstruction should be continued.