Idorsia Ltd (SIX:IDIA) has received FDA approval for 25- and 50-mg doses of Quviviq (daridorexant), a dual orexin receptor antagonist.
Quiviviq is the first compound in its pipeline to win FDA approval.
The drug works differently from traditional benzodiazepines, which modulate neuronal activity. By contrast, daridorexant inhibits the binding of orexins to reduce excessive wakefulness.
FDA approved the drug based on Phase 3 data that showed that the drug offered faster sleep onset and better sleep maintenance over placebo. In the study, the drug was also associated with longer total sleep time, which enrolled 1,854 adults with insomnia in 18 countries.
“After more than 20 years of research and a progressive understanding of the role of orexin in sleep-wake balance and of the potential of orexin receptor antagonism, we designed daridorexant to help address several issues people with insomnia face,” said Dr. Martine Clozel, chief scientific officer. “Daridorexant properties include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects.”
FDA has recommended that the Drug Enforcement Administration (DEA) classify Quviviq as a controlled substance. Allschwil, Switzerland–based Idorsia anticipates that the drug will hit the market in the summer.
Roughly one-third to half of adults have intermittent insomnia symptoms, while about 10–15% have chronic insomnia, according to the Cleveland Clinic.
Idorsia saw IDIA shares tick down 5.54% to $20.45 after announcing the FDA approval.
The company was incorporated in 2017.
Idorsia has several other products in Phase 3 trials.
The company also has a collaboration agreement with Janssen, which it announced in 2017.
Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs