Nxera insomnia treatment creates a buzzzz in Japan

The approval of QUVIVIQ, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data including from a dedicated Japanese Phase 3 trial. Plans to make QUVIVIQ available as soon as possible to insomnia patients in Japan are underway.

Insomnia, characterised by difficulties in sleep onset and/or sleep maintenance, is highly prevalent in Japan, affecting about 20 per cent of adults according to welfare chiefs in the country, and is recognised as an important national issue impacting both physical and mental health.

Makoto Uchiyama, medical adviser of the Japanese Phase 3 study, said: “Insomnia is highly prevalent in Japan and is recognised 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 centres in Japan, to show increased total sleep time and shortened sleep latency in patients with insomnia without marked hangover symptoms the next morning.

“Providing QUVIVIQ to Japanese healthcare professionals is of great significance and I believe we can change the quality of life of many patients with insomnia.”

Satoshi Tanaka, President of Nxera Pharma Japan, and Executive Officer and Executive Vice President of Nxera Pharma, added: “We are grateful to the investigators who have cooperated in conducting clinical studies in more than 600 Japanese patients and to the patients who have participated in the trials.

“I also thank the Nxera Pharma Japan team, many of whom have worked on QUVIVIQ for many years and never doubted the benefit that it could bring to patients.

“The unique characteristics of QUVIVIQ offer patients with insomnia not only a better night sleep but also an improvement in daytime functioning. We are very pleased to bring this dual orexin receptor antagonist, QUVIVIQ, to patients with insomnia in Japan where orexin was discovered.”