Nxera Pharma Co. announced positive top-line results from a phase 3 study conducted in South Korea evaluating daridorexant 50 mg in adult and elderly patients with insomnia.
The successful phase 3 trial is designed to evaluate the efficacy and safety of daridorexant in adult and elderly patients with insomnia. Patients were randomized to receive daridorexant 50 mg or placebo once daily for 28 days. The study met both its primary and secondary efficacy endpoints. At Day 28, daridorexant significantly improved the primary efficacy endpoint, the change from baseline in subjective total sleep time, compared with placebo. Daridorexant also significantly improved the secondary efficacy endpoints, the change from baseline at Day 28 in subjective latency to sleep onset and subjective wake after sleep onset, compared with placebo.
The company plans to submit a marketing authorization application for daridorexant in South Korea in the first quarter of 2026, with approval expected in the first quarter of 2027.
Daridorexant is a dual orexin receptor antagonist (DORA) that equipotently antagonizes orexin receptors 1 and 2, consequently decreasing overactive wake signals throughout the entire night
The drug is approved and being marketed in Japan as Quviviq under a commercialization agreement between Nxera and Shionogi. Discovered by Idorsia Pharmaceuticals, Quviviq 25 mg and 50 mg tablets were approved by the U.S. FDA in January 2022 and are marketed by Idorsia in the U.S., Canada, and multiple European countries.