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FDA authorises Jazz Pharma's sleep disorder therapy Sunosi

Published on 22/03/19 at 11:11am

Jazz Pharmaceuticals has announced that its dopamine and norepinephrine reuptake inhibitor (DNRI) Sunosi (solriamfetol) has been approved by the FDA as a therapy to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnoea (OSA).

The authorisation covers doses of 75 mg and 150 mg in narcolepsy and 37.5 mg, 75 mg, and 150 mg in OSA, and marks the first approval of a dual-acting DNRI in this indication.

Phase 3 data from four randomised studies submitted in support of the application illustrated that Sunosi proved superiority in treatment compared to placebo; after 12 weeks, 68-74% of patients taking the 75% dose and 78-90% of those taking the 150mg dose reported an improvement in their condition according to the Patient Global Impression of Change (PGIc) scale, and this was shown to remain effective for six months after use.

“Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnoea at work, at home or in daily activities,” commented Bruce Cozadd, Chairman and Chief Executive Officer of Jazz Pharmaceuticals. “With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients. 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.”

Daniel Swisher, President and Chief Operating Officer at Jazz, also added: “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 apnoea and narcolepsy patients with excessive daytime sleepiness.”

Matt Fellows

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