The first batch of express in 2022, FDA today approves innovative insomnia therapy

▎WuXi AppTec Content Team Editor On January 10, 2022, Idorsia announced that the U.
S.
FDA has approved Quviviq (daridorexant) for the treatment of adult patients with insomnia
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Insomnia is a severe sleep disorder characterized by difficulty initiating and/or maintaining sleep
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Quviviq is a dual orexin receptor antagonist
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Unlike normal brain-sedating therapies, it inhibits hyperactive insomnia by blocking the binding of the wake-promoting neuropeptide orexin
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This approval is based on positive results from a Phase 3 clinical program
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The program is divided into two pivotal trials involving a total of 1,854 adults with insomnia who were randomized to receive different doses of Quviviq or a once-daily placebo
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The primary efficacy endpoints of both trials were the change in time required to enter sustained sleep (LPS) and wake after sleep onset (WASO) from baseline to months 1 and 3
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LPS is an indicator of sleep onset and WASO is an indicator of sleep maintenance
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A secondary endpoint of the trial was patient-reported total sleep time (sTST)
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▲ Orexin stimulates multiple signaling pathways that promote wakefulness (Image source: Reference [2]) The results of this phase 3 clinical project showed that compared with the placebo group, Quviviq at a dose of 50 mg significantly improved the objective of sleep onset and sleep maintenance in patients metrics, and total patient-reported sleep time
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Quviviq also significantly reduced daytime sleepiness in patients at the 50 mg dose level
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In terms of safety, the most common adverse reactions were headache, drowsiness or fatigue
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Dr.
Martine Clozel, Chief Scientific Officer of Idorsia, said: "After more than 20 years of research and a progressive understanding of the role of orexin in sleep-wake balance and the potential for orexin receptor antagonism, we have designed daridorexant to help address insomnia.
Multiple problems faced by patients
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The properties of Daridorexant include potent inhibition of two orexin receptors, rapid absorption, which aids in falling asleep, and favorable pharmacokinetic profile
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About 80% of the drug is eliminated after nighttime sleep , can help minimize carryover effects
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” Reference: [1] Idorsia receives US FDA approval of Quviviq (daridorexant) 25 and 50 mg for the treatment of adults with insomnia.
Retrieved January 10, 2022, from https:// Idorsia Company Presentation.
Retrieved April 19, 2020, from https:// -company-presentation.
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