Nxera Pharma's QUVIVIQ Approved in Japan for Insomnia Treatment

Nxera Pharma Co., Ltd. (formerly Sosei Group) has announced that its Japanese subsidiary, Nxera Pharma Japan Co., Ltd. (NPJ), has gained approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for its New Drug Application (NDA) for QUVIVIQ™ (daridorexant) in 25 mg and 50 mg doses. This medication is intended for adult patients with insomnia and represents a novel class of treatment as a dual orexin receptor antagonist. The approval stems from comprehensive clinical efficacy and safety data, notably from a Phase 3 trial conducted in Japan that successfully met all primary and secondary endpoints.

Insomnia, which entails difficulty in initiating or maintaining sleep, affects approximately 20% of Japanese adults, as reported by the MHLW. It is recognized nationally as a significant health issue, impacting both physical and mental well-being. Dr. Makoto Uchiyama, a medical advisor for the Phase 3 study and a distinguished professional in the field of sleep medicine, highlighted the critical nature of insomnia in Japan. He pointed out that QUVIVIQ is the first drug in a decade to be thoroughly studied across more than 100 centers in Japan, showing notable improvements in total sleep time and reductions in sleep latency without significant next-morning hangover effects. He emphasized the importance of providing this medication to healthcare professionals to potentially enhance the quality of life for many patients.

Satoshi Tanaka, President of Nxera Pharma Japan, expressed gratitude towards the investigators and patients involved in the clinical studies, as well as the Nxera Pharma Japan team for their persistent efforts. He underscored the unique benefits of QUVIVIQ in offering not only better night sleep but also improved daytime functioning for patients with insomnia.

The MHLW's approval of QUVIVIQ is backed by positive results from a randomized, double-blind, placebo-controlled Phase 3 study conducted in Japan. The study aimed to assess the efficacy and safety of daridorexant. This trial successfully met its primary efficacy endpoints, which included significant improvements in subjective total sleep time (sTST) and reductions in subjective latency to sleep onset (sLSO). Both doses of daridorexant (25 mg and 50 mg) demonstrated statistically significant improvements compared to placebo, with p-values indicating strong efficacy (p<0.001 for 50 mg, p=0.042 for 25 mg for sTST and p<0.001 for 50 mg, p=0.006 for 25 mg for sLSO). The incidence of adverse events was similar between the daridorexant and placebo groups, with treatment-emergent adverse events reported in 23.5% and 22.7% of patients for the 50 mg and 25 mg doses respectively, compared to 24.4% for placebo.

Insomnia disorder, characterized by persistent difficulties in sleep that impair daytime functioning, is a condition of overactive wake signaling. The disorder significantly affects daily life, including concentration, mood, and energy levels. Treatments aim to enhance sleep quality and quantity while minimizing adverse effects.

QUVIVIQ works by targeting the orexin system, which regulates wakefulness. Orexin neuropeptides, particularly orexin A and orexin B, promote wakefulness. By antagonizing these receptors, QUVIVIQ helps mitigate the overactivity of wake signaling, a primary driver of insomnia.

The Japanese Phase 3 study enrolled 490 patients in a multicenter, double-blind, placebo-controlled setup to evaluate the efficacy of 50 mg and 25 mg daridorexant versus placebo. The trial's primary objectives were to measure changes in sTST and sLSO from baseline to Week 4. The study revealed significant improvements in these primary endpoints, supporting the efficacy of daridorexant in treating insomnia.

Nxera Pharma, with its rebranding from Sosei Heptares, is dedicated to developing new specialty medicines addressing unmet medical needs. It operates a diverse pipeline targeting various therapeutic areas and leverages its GPCR-targeted drug discovery platform, NxWaveTM. With over 350 employees across key global locations, Nxera continues to advance its mission in improving patient outcomes.