SHIONOGI and Nxera Pharma Introduce QUVIVIQ in Japan for Adult Insomnia

OSAKA, Japan – Shionogi & Co., Ltd., a pharmaceutical company headquartered in Osaka, in partnership with Nxera Pharma Co., Ltd., based in Tokyo, has introduced QUVIVIQ™ (daridorexant) to the Japanese market as a novel treatment for adults dealing with insomnia. This medication is available in 25 mg and 50 mg doses and is designed to aid individuals suffering from sleep difficulties.

QUVIVIQ™ functions as a Dual Orexin Receptor Antagonist. It works by selectively targeting orexin receptors (OX1R and OX2R), known for their role in promoting wakefulness, thereby reducing excessive alertness and assisting in the transition to sleep. Under the terms of the commercial partnership agreement, Shionogi will manage the distribution and sales operations of QUVIVIQ™ in Japan, while Nxera Pharma Japan Co., Ltd., a subsidiary of Nxera Pharma, holds the approval and will partly handle the provision of the drug.

The launch of QUVIVIQ™ marks a significant milestone for Nxera, underscoring its capabilities in developing innovative treatments for Japanese patients. This aligns with Nxera's strategic goal of being a leading partner for companies aiming to launch new therapies in Japan. Meanwhile, Shionogi is focusing on strengthening its presence in the 'Quality of Life (QOL) disease area,' a sector less subject to market trends, with QUVIVIQ™ at the forefront of this initiative.

The collaboration between Shionogi and Nxera is aimed at delivering QUVIVIQ™ promptly to address the needs of individuals suffering from insomnia. This partnership is anticipated to provide a long-term solution for patients seeking improved sleep quality and daytime functioning.

QUVIVIQ™ was initially developed by Idorsia Pharmaceuticals Ltd. and has shown positive results in Phase 3 trials for Japanese patients with insomnia. By September 2024, Nxera Pharma Japan secured the production and marketing approval for QUVIVIQ™ as a treatment for insomnia in adults. The drug is already available in the United States, Europe, and Canada under the same brand name by Idorsia Pharmaceuticals Ltd.

Insomnia is characterized by difficulty in initiating or maintaining sleep, leading to significant distress or impairment in important areas of daytime functioning. This condition involves hyperactive wake signaling, with brain areas associated with wakefulness remaining active during sleep in insomnia patients. According to a 2018 survey by Japan’s Ministry of Health, Labour and Welfare, around 20% of Japanese adults experience inadequate rest from sleep.

Unlike brief episodes of poor sleep, insomnia is a chronic condition that affects both physical and mental health. It hampers daytime functioning and has been linked to various negative outcomes, including impaired concentration, mood disturbances, and reduced energy levels. Treatment goals for insomnia focus on enhancing sleep quality and quantity, alongside improving daytime functioning while minimizing adverse effects. Recommended treatments encompass sleep hygiene practices, cognitive behavioral therapy, and pharmacotherapy.

Shionogi is dedicated to providing optimal healthcare solutions to enhance the health and well-being of the communities it serves. The company aims to contribute to a healthier society where individuals can lead fulfilling and vibrant lives. Nxera Pharma, previously known as Sosei Heptares, is committed to developing specialty medicines that address unmet medical needs in Japan and worldwide.