u200cFDA批准达利雷生(Quviviq)用于治疗失眠症

‌FDA approves Quviviq for the treatment of insomnia

On January 10, 2022, Alschwil, Switzerland—Idorsia Ltd announced that the U.S. Food and Drug Administration (FDA) has approved Quviviq 25 mg and 50 mg for the treatment of insomnia in adults. The drug is targeted at patients with difficulty falling asleep and/or sleep maintenance disorders. The FDA's approval was based on an extensive clinical program involving more than 160 clinical trial sites in 18 countries and a total of 1,854 insomnia patients. Insomnia, a serious medical condition, is the most common sleep disorder in the United States.

The innovative mechanism and clinical effect of dual orexin receptor antagonists

Based on the antagonism of dual orexin receptors, it can exert its obvious hypnotic effect by specifically blocking the binding of orexin, a neuropeptide that promotes wakefulness. Its mechanism of action is very different from traditional drugs that calm the brain, but improves sleep by regulating the hyperactivity of the human body's arousal state. In a Phase III clinical program, Quviviq showed significant superiority to placebo on objective sleep parameters (initiation and sleep maintenance) and total patient-reported sleep time. Evaluation of the US prescription dose of 50mg in two key clinical studies ultimately showed that it can significantly reduce patients' daytime sleepiness (both using relatively reliable scales). The most common adverse reactions (incidence ≥5% and higher than the placebo group) were headache (5% in the placebo group, 6% in the 25mg group, and 7% in the 50mg group) and drowsiness or fatigue (4% in the placebo group, 6% in the 25mg group, and 5% in the 50mg group).

‌Expert Evaluation and Market Outlook

The FDA recommends that Quviviq be classified as a controlled drug and is expected to be launched in May 2022 after the U.S. Drug Enforcement Administration completes the classification.

After more than 20 years of unremitting efforts and exploration, we have gradually uncovered the crucial role of orexin in regulating the body's sleep-wake balance. At the same time, we have also initially revealed the potential prospects of new treatment methods that antagonize its receptors. Quviviq is designed to solve the multiple problems of patients with insomnia. Its characteristics include strong inhibition of dual orexin receptors, rapid absorption to promote falling asleep, and pharmacokinetic properties-about 80% of the drug can be metabolized during sleep after a single dose, thereby minimizing residual effects.

Dr. Thomas Roth, director of the Sleep Disorders and Research Center at Henry Ford Hospital, pointed out: According to the definition of insomnia, the disease not only affects nighttime sleep, but also impairs patients' daytime functions. Although the burden of insomnia on individuals and society is well recognized, emphasizing its impact on circadian functioning is critical to addressing patient needs. This new treatment brings hope to the millions of adults suffering from insomnia.

Patricia Torr, President and General Manager of Idorsia US, said: As an innovative, patient-centered company, Idorsia is proud to have received its first FDA approval. Quviviq redefines the insomnia treatment paradigm by helping patients fall asleep faster and stay asleep longer, thereby improving their state of mind the next day. We have differentiated products, an excellent team and an innovative strategy, and are confident in the success of Quviviq.

Dr. Guy Braunstein, global head of clinical development at Idorsia, added: The study of daridorexant confirmed its improvement in objective sleep parameters and improvement in patient-reported outcomes. The efficacy of this drug is obviously dose-dependent, but the incidence of drowsiness or fatigue caused by it does not increase with the increasing dose of the drug.