Health Canada has granted marketing authorization for Idorsia Ltd’s Quviviq (daridorexant) for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Quviviq is a dual orexin receptor antagonist acting on both orexin 1 and orexin 2 receptors equipotently. Rather than inducing sleep through broad inhibition of brain activity (sedation), Quviviq blocks only the activation of orexin receptors which promote wakefulness. Consequently, for patients with insomnia, Quviviq decreases the over-active wake drive, allowing sleep to occur, without altering the proportion of sleep stages.
The recommended dose of Quviviq is one tablet of 50 milligrams once per night, taken orally in the evening within 30 minutes before going to bed, with at least seven hours remaining prior to planned awakening. Some patients may be treated with 25 milligrams once per night.
“I’m very pleased with the positive decision from Health Canada, particularly seeing the recommended dose of 50 milligrams, which we know works best,” says Jean-Paul Clozel, MD, Idorsia CEO, in a news release. “It is estimated that 8.8% of adults in Canada suffer from chronic insomnia, which we know takes its toll on their physical and mental health. Sleep is one of the key pillars of health, so for these patients, regular, nightly use of Quviviq can have a big impact on both their night’s sleep and their daily life.”
The decision by Health Canada is supported by robust phase 3 results—published in The Lancet Neurology—which demonstrated that, at the recommended dose, Quviviq improved sleep onset, sleep maintenance, and self-reported total sleep time in adults with insomnia disorder. The effects of Quviviq on sleep variables were observed early in treatment and were maintained over time.
The most frequently reported adverse reaction during the double-blind treatment period in phase 3 clinical trials with Quviviq was headache. The majority of adverse reactions were mild to moderate in intensity. No evidence of a dose-relationship for the frequency or severity of adverse reactions was observed. The adverse reaction profile in elderly patients was consistent with younger patients. There was no indication of non-medicinal use and no evidence of withdrawal symptoms upon drug discontinuation. This suggests that Quviviq does not produce physical dependence. No sign of rebound insomnia was observed upon treatment discontinuation.
The marketing authorization was also supported by a long-term follow-up extension study, which together with the pivotal trials, provides clinical data for up to 12 months of cumulative treatment.
In January 2022, Quviviq was approved by the US Food and Drug Administration and subsequently made commercially available in May 2022. In April 2022, marketing authorization of Quviviq was granted by the European Commission and subsequently by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain via the European Commission Decision Reliance Procedure. Launch preparations are underway in the major European markets. Quviviq was made available in both Italy and Germany in November 2022. Marketing authorization of Quviviq was granted by Swissmedic in December 2022, and the company aims to make Quviviq available to patients in Switzerland in June.
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