Quviviq, a dual orexin receptor antagonist, has been approved in Japan for the treatment of adult insomnia, based on positive data from a phase 3 trial.
Summary: Nxera Pharma Japan Co, a subsidiary of Nxera Pharma, received approval from Japan’s Ministry of Health, Labour, and Welfare for Quviviq (daridorexant) 25 mg and 50 mg to treat adult insomnia. The approval is based on clinical efficacy and safety data from a Japanese phase 3 trial, where Quviviq improved sleep onset and total sleep time without significant hangover effects. Insomnia is a major health issue in Japan, affecting 20% of adults.
Three Key Takeaways:
- Quviviq Approved for Insomnia in Japan – The Ministry of Health, Labour, and Welfare approved Quviviq, a dual orexin receptor antagonist, for the treatment of adult insomnia, following positive results from a phase 3 clinical trial.
- Clinical Efficacy and Safety Confirmed – The phase 3 trial demonstrated significant improvements in sleep onset and total sleep time, with no major differences in adverse events compared to placebo.
- Insomnia’s High Prevalence in Japan – Insomnia affects 20% of Japanese adults, and Quviviq’s approval offers a new treatment option to address this issue.
Nxera Pharma Co, formerly known as Sosei Group or Sosei Heptares, announced that Nxera Pharma Japan Co received approval from the Ministry of Health, Labour, and Welfare of Japan of its New Drug Application for Quviviq (daridorexant) 25 and 50 mg for the treatment of adult patients with insomnia.
The approval of Quviviq, a novel dual orexin receptor antagonist, is based on clinical efficacy and safety data including from a Japanese phase 3 trial. Plans are underway to make Quviviq available as soon as possible to insomnia patients in Japan, according to a release from Nxera Pharma.
Insomnia is highly prevalent in Japan, affecting about 20% of Japanese adults, according to the Ministry of Health, Labour, and Welfare, and is recognized as an important national issue impacting both physical and mental health.
“Insomnia is highly prevalent in Japan and is recognized as an important national health issue. The disorder is not only a problem of the night but affects a patient’s ability to function during the day. Quviviq is the first drug for a decade, clinically investigated in more than 100 centers in Japan, to show increased total sleep time and shortened sleep latency in patients with insomnia without marked hangover symptoms the next morning,” says Makoto Uchiyama, MD, PhD, medical advisor of the Japanese phase 3 study, director of Tokyo Adachi Hospital, lecturer of Nihon University School of Medicine, and visiting professor of Toho University, in a release.
Positive Phase 3 Data
The approval of Quviviq is supported by positive results of a randomized, double-blind, placebo-controlled phase 3 study in Japan to investigate the efficacy and safety of daridorexant. The study met all primary and secondary efficacy endpoints. Daridorexant significantly improved subjective total sleep time, a primary endpoint defined as the change from baseline compared to placebo at 28 days.
Daridorexant also significantly improved sleep onset as measured by a decrease in subjective latency for sleep onset, a primary endpoint defined as the change from baseline compared to placebo at 28 days. The rate of adverse events was comparable between placebo and daridorexant at both treatment doses. Treatment-emergent adverse events during the double-blind study period were reported in 23.5% and 22.7% of the patients treated with 50 mg and 25 mg daridorexant, respectively (24.4% for placebo).
Daridorexant is approved in the United States and Europe and marketed in these territories under the brand name Quviviq by Idorsia Pharmaceuticals.
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