Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
Once-daily Sunosi is approved 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. This medication is not indicated to treat the underlying airway obstruction in OSA.
Sunosi is expected to be commercially available in the U.S. following the final scheduling decision by the U.S. Drug Enforcement Administration (DEA), which is typically within 90 days of FDA approval.
“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,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “The FDA approval of Sunosi also represents an important milestone for Jazz as we continue to offer new treatment options that address unmet needs for people living with chronic, and often debilitating, sleep disorders.”
The FDA’s approval of Sunosi is based on data from the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) Phase 3 clinical program, which included four randomized placebo-controlled studies that demonstrated the superiority of Sunosi relative to placebo. The most common adverse reactions (incidence ≥5% and higher than placebo) reported in both the narcolepsy and OSA study populations were headache, nausea, decreased appetite, and anxiety. Sunosi was evaluated in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea and was shown to maintain its effect relative to placebo after six months of use.
“We’re excited about this new therapeutic option for patients, and we are pleased with the information included in the Sunosi label as we believe it will give physicians the information needed to appropriately manage the vast majority of obstructive sleep apnea and narcolepsy patients with excessive daytime sleepiness,” said Daniel Swisher, president and chief operating officer of Jazz Pharmaceuticals.
Although the exact mechanism of action is unknown, the effects of Sunosi are thought to be mediated through its activity as a DNRI.
“Sunosi is an effective treatment option with a novel mechanism of action as a dual-acting dopamine and norepinephrine reuptake inhibitor,” said Richard K. Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine and Chief Medical Officer at SleepMed in Columbia, South Carolina. “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.”
from Sleep Review http://www.sleepreviewmag.com/2019/03/jazz-pharm-fda-sunosi-solriamfetol-daytime-sleepiness-associated-with-narcolepsy-obstructive-sleep-apnea/