Jazz Pharmaceuticals, SK Biopharmaceutical’s U.S. partner, has received sales approval from the FDA for Sunosi (Ingredient: solriamfetol), a treatment to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
The approval marks 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 U.S. Food and Drug Administration.
The drug is also the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA to improve wakefulness in adults living with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
SK Biopharmaceutical discovered solriamfetol and completed its phase 1 clinical trial before licensing out the substance to Aerial BioPharma in 2011. Afterward, 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.
Jazz expects that Sunosi will be commercially available in the U.S. following the final scheduling decision by the U.S. Drug Enforcement Administration, which is typically within 90 days of FDA approval.
The FDA approved the drug based on the company’s data from the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) phase 3 clinical trials. The research included four randomized placebo-controlled studies that demonstrated the superiority of Sunosi relative to placebo in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
The most common adverse reactions reported in both the narcolepsy and OSA (obstructive sleep apnea) study populations were headache, nausea, decreased appetite, and anxiety. The drug also maintained its effect relative to placebo after six months of use.
"Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea 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," Jazz Pharmaceuticals CEO and Chairman Bruce Cozadd said.
The FDA approval of Sunosi also represents an essential milestone for Jazz as it continues to offer new treatment options that address unmet needs for people living with chronic, and often debilitating, sleep disorders, Cozadd added.
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