Research & Development
Jazz Pharmaceuticals wins the US FDA's approval for Sunosi (solriamfetol) for treating Narcolepsy or Obstructive Sleep Apnea
21 March 2019 -

Biopharmaceutical company Jazz Pharmaceuticals plc (Nasdaq:JAZZ) revealed on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

The company added that the US FDA has approved once-daily Sunosi in doses of 75mg and 150mg for patients with narcolepsy and in doses of 37.5mg, 75mg and 150mg for patients with OSA.

According to the company, Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to treat excessive daytime sleepiness in adults living with narcolepsy or OSA.

In the US, Sunosi is expected to be launched upon the final scheduling decision by the US Drug Enforcement Administration (DEA) within 90 days of FDA approval.

This FDA's approval of Sunosi is based on data from the company's Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) Phase 3 clinical programme, which included four randomized placebo-controlled studies in 900 adults. In 12 week clinical studies, about 68-74% of people at the 75mg dose and 78-90% of people at the 150mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change (PGIc) scale.

Narcolepsy is a chronic, debilitating neurological disorder characterized by excessive daytime sleepiness, and the inability to regulate sleep-wake cycles normally.

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