RARE Daily

FDA Approves Jazz Pharmaceuticals’ Narcolepsy Drug

March 21, 2019

Rare Daily Staff

The U.S. Food and Drug Administration approved Jazz Pharmaceuticals’ drug Sunosi to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

Photo: Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals

Narcolepsy is a chronic, debilitating, rare neurological disorder characterized by excessive daytime sleepiness and the inability to regulate sleep-wake cycles normally. It affects an estimated one in 2,000 people in the United States, with symptoms typically appearing in childhood. It is estimated that more than half of patients with narcolepsy have not been diagnosed. Studies have shown it may take 10 years or more for people with narcolepsy to receive a diagnosis.

Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize Sunosi from Aerial Biopharma. Sunosi has orphan drug designation for narcolepsy in the United States.

“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,” said Bruce Cozadd, chairman and CEO 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’s approval of Sunosiis based on data from the phase 3 clinical program, which included four randomized placebo-controlled studies that demonstrated the superiority of Sunosi relative to placebo. At week 12, 150 mg of Sunosi for narcolepsy patients and all doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed in test sessions approximately one hour post-dose through approximately nine hours post-dose of the maintenance of wakefulness test.

Approximately 68-74 percent of people taking Sunosi at the 75 mg dose and 78-90 percent of people taking Sunosi at the 150 mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change scale.

Although the exact mechanism of action is unknown, the effects of Sunosi are thought to be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor.

The most common adverse reactions reported in both the narcolepsy and obstructive sleep apnea study populations were headache, nausea, decreased appetite, and anxiety. Sunosiwas 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.

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