Jazz Pharmaceuticals gets FDA nod for Sunosi
Jazz Pharmaceuticals has received the Food and Drug Administration’s approval for Sunosi (solriamfetol). The drug is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA for this condition, the company said. The once-daily drug can be used at dosage strengths of 75 mg and 150 mg for patients with narcolepsy and dosage strengths of 37.5 mg, 75 mg, and 150 mg for patients with obstructive sleep apnea.
"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 chairman and CEO Bruce Cozadd said. "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."
"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," Jazz president and COO Daniel Swisher said.
Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA for this condition, the company said. The once-daily drug can be used at dosage strengths of 75 mg and 150 mg for patients with narcolepsy and dosage strengths of 37.5 mg, 75 mg, and 150 mg for patients with obstructive sleep apnea.
"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 chairman and CEO Bruce Cozadd said. "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."
"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," Jazz president and COO Daniel Swisher said.