Nxera Pharma has reported positive top-line results from its Phase III trial of daridorexant 50mg, a treatment for insomnia in adults and the elderly in South Korea. The company plans to submit a marketing authorization application in the first quarter of 2026, with an expected approval by the first quarter of 2027.
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Daridorexant is marketed as Quviviq in Japan through a partnership between Nxera and Shionogi. In addition, Idorsia Pharmaceuticals is promoting the drug in Canada, the US, and several European countries, while Simcere is responsible for distribution in Hong Kong and China.
Insomnia, which affects 15%-25% of the adult population in South Korea, has significant implications for both physical and mental health. The Phase III study was a placebo-controlled, double-blind, randomized, multi-center trial designed to evaluate the safety and efficacy of daridorexant.
Participants received either daridorexant 50mg or a placebo daily for 28 days. The study successfully met all primary and secondary efficacy endpoints. Results indicated that daridorexant significantly improved subjective total sleep time by day 28 compared to placebo. Additionally, enhancements were seen in secondary endpoints, including subjective wake after sleep onset and subjective latency to sleep onset.
The rate of adverse events was comparable between the two groups, with treatment-emergent adverse events reported at 13.41% for the daridorexant group and 14.81% for the placebo group.
MinBok Lee, president and representative director of Nxera Pharma Korea, stated that insomnia is a prevalent health issue in South Korea. He expressed optimism about the Phase III study results, describing them as a critical milestone for advancing access to new treatment options for patients suffering from insomnia in the region. He emphasized the company's commitment to making Quviviq available to South Korean patients as swiftly as possible.