FDA grants approval to insomnia drug

The FDA granted approval to Quviviq to treat adults with insomnia.

Quviviq (daridorexant, Idorsia) is a dual orexin receptor antagonist that blocks the binding of wake-promoting neuropeptides orexins and is thought to minimize overactive wakefulness, as opposed to sedative treatments.

“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,” Martine Clozel, MD, chief scientific officer of Idorsia, said in a company release. “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.”

Daridorexant was cleared for doses of 25 mg and 50 mg on the heels of two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies during a phase 3 clinical program, which included 1,854 patients encompassing 160 clinical trial sites in 18 countries.

Participants received daridorexant or placebo once a day, in the evening, for 3 months. Researchers on the first study randomly assigned 930 participants to a 50-mg dose, while 924 participants received the 25-mg dose in the second study. Both studies included a 7-day placebo run-out period, after which patients could enter a 9-month, double-blind, placebo-controlled extension study. A total of 600 participants were treated for at least 6 months of cumulative therapy, including 373 treated for at least 12 months.

The drug produced effective boosts to patients’ sleep onset, maintenance and time. The 50-mg dose produced measurable easing of patients’ daytime somnolence.

The FDA recommended daridorexant be classified as a controlled substance. It is scheduled to be released to the public in May 2022.