Jazz Pharmaceuticals, SK Biopharmaceutical's U.S. partner, announced that the U.S. Drug Enforcement Agency (DEA) has designated Sunosi (Ingredient: solriamfetol), a sleepiness treatment, as a Schedule IV medicine, setting Jazz up for a launch next month.
Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
Beginning early July, once-daily Sunosi will be commercially available in the U.S. in 75 mg and 150 mg tablets.
"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," Jazz Pharmaceuticals CEO and Chairman Bruce Cozadd said. “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."
Jazz obtained approval for the drug from the U.S. Food and Drug Administration in March of this year.
The approval marked the first drug approval for SK Biopharmaceutical and also the first time a new drug for a central nervous system developed by a local company received approval from the FDA.
SK Biopharmaceutical discovered solriamfetol and completed its phase 1 clinical trial before licensing out the substance to Aerial BioPharma in 2011. Later, Jazz Pharmaceuticals took over the global commercialization rights, including the U.S. and Europe, to complete the phase 3 clinical trials for the drug.
Currently, SK Biopharmaceutical holds rights in 12 countries in Asia, including Korea, China, and Japan. With the FDA's approval, the company plans to start the commercialization process in Asia, the company said.