Idorsia receives US FDA approval for the treatment of insomnia

Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has approved QUVIVIQ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance1. The FDA approval of QUVIVIQ is based on an extensive clinical program that included 1,854 adults with insomnia at over 160 clinical trial sites across 18 countries. Insomnia, a serious medical condition, is the most common sleep disorder in the US.

QUVIVIQ is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain.

During the Phase 3 clinical program, QUVIVIQ demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, and patient reported total sleep time. Consistent with the US prescribing information, the 50 mg dose of QUVIVIQ, which was evaluated in one of the two pivotal studies, demonstrated a significant reduction in patient reported daytime sleepiness, using a validated instrument. The most common adverse reactions (in at least 5% of patients and greater than placebo) were headache (placebo: 5%, 25 mg: 6%, 50 mg: 7%,) and somnolence or fatigue (placebo: 4%, 25 mg: 6%, 50 mg: 5%).

The FDA has recommended that QUVIVIQ be classified as a controlled substance and it is anticipated to be available to patients in May 2022, following scheduling by the US Drug Enforcement Administration.

Martine Clozel, MD and Chief Scientific Officer of Idorsia, commented: “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. 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.”

Dr Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital, commented: “As noted in the definition of insomnia, the disorder is not only a problem of the night but affects a patient’s ability to function during the day. Although the personal and societal burden of insomnia is well established, elevating the impact insomnia has on both the night and day remains critical in addressing patients’ needs. I am encouraged to see a new advanced treatment option for the millions of adults struggling with insomnia.”

Patricia Torr, President and General Manager of Idorsia US added: “I am extremely proud to be leading the US organization of such a forward-thinking and patient-centric organization like Idorsia. With this first FDA approval for our company, QUVIVIQ provides a new treatment option that can help adults with insomnia get to sleep faster and stay asleep longer, which we know plays an important role in how they feel the next day. It’s an incredibly exciting time for us and I can’t wait to transform the treatment paradigm in the US. We have a differentiated product, an amazing team, and an innovative strategy, giving me absolute confidence that we can make QUVIVIQ a great success.”

Guy Braunstein, MD and Head of Global Clinical Development of Idorsia, commented: “In our investigation of daridorexant we were able to demonstrate an improvement on objective sleep parameters, as well as improvement in patient-reported outcomes. What is truly impressive, we have shown a dose response in the efficacy of daridorexant, with no increase in the rate of somnolence or fatigue with increasing doses.”