Simcere Pharma (02096.HK) announced on July 16th that the new insomnia drug Suvorexant (generic name: darilay) under collaboration with Idorsia Pharmaceuticals Ltd. (Idorsia) has been accepted for new drug application (NDA) by China National Medical Products Administration (NMPA) on July 16th, 2024.
Darilay is a dual orexin receptor antagonist (DORA) that blocks the binding of orexin neuropeptides (orexin A and orexin B) which promote wakefulness to their receptors. Different from promoting sleep through sedation, darilay only blocks the activation of orexin neuropeptides on orexin receptors. Therefore, darilay reduces wake-promoting drive, induces sleep onset without altering sleep architecture. The Phase III overseas data of Darilay have been published in The Lancet Neurology. The primary study shows that during the first and third months of treatment, Darilay significantly improves sleep onset, sleep maintenance and prolongs total sleep time reported by patients compared with placebo, without changing sleep architecture. In addition, the study also shows that Darilay has good safety and tolerability, with no evidence of rebound insomnia, withdrawal symptoms and drug abuse, which distinguishes it significantly from results reported for benzodiazepine receptor agonists. Darilay has obtained clinical data for up to 12 months of continuous treatment, supporting the long-term use of darilay. Darilay not only improves nighttime sleep in adult patients with chronic insomnia but also improves daytime function, which is the only DORA class of insomnia drug approved by the European Medicines Agency (EMA) to improve daytime function. Previously, Darilay (trade name: QUVIVIQ) has been approved in the United States, United Kingdom, Italy, Germany, Switzerland, and Canada.