Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced topline results from a Phase III clinical study for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd, a Swiss pharmaceutical company. The study evaluated the efficacy and safety of daridorexant in Chinese patients with insomnia and successfully met its primary endpoint. The findings indicated that daridorexant significantly improved various sleep-related indicators, including nocturnal awakenings in insomnia patients, compared to placebo. The drug demonstrated a favorable safety profile and was well-tolerated. The company plans to submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for market approval.
Daridorexant differentiates itself from traditional insomnia treatments, such as benzodiazepines, by reducing the arousal drive and promoting sleep not through brain sedation but by blocking the activation of orexin receptors. This mechanism does not alter the sleep structure of patients and is devoid of residual effects the following day.
Quviviq is already commercially available in several countries, including the US, UK, Italy, Germany, Switzerland, and Canada. Jiangsu Simcere Pharmaceutical obtained the rights to develop and commercialize Quviviq exclusively in Greater China through a licensing agreement with Idorsia Pharmaceuticals in November 2022.- Flcube.com
