Solriamfetol to treat narcolepsy, OSAMay 8, 2019
The US FDA has approved solriamfetol (Sunosi) to treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA), Jazz Pharmaceuticals Plc said.
Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or OSA.
The drug is expected to be commercially available in the US following the final scheduling decision by the Drug Enforcement Administration (DEA).
The FDA’s approval of solriamfetol is based on data from the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) phase 3 clinical programmes, which included four randomized placebo-controlled studies that demonstrated the superiority of the drug relative to placebo.
The approval comes as Jazz is trying to reduce its reliance on its blockbuster narcolepsy drug, Xyrem, whose patents were declared invalid by a US appeals court in July.