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Recently, the European Committee for Medicinal Products for Human Use (CHMP) has recommended Quviviq (daridorexant) as the first dual-acting orexin receptor antagonist in the European Union for the treatment of adult patients with insomnia
.
This notion is supported by pivotal Phase III data recently published in The Lancet Neurology
.
The results showed that daridorexant improved nighttime symptoms and daytime functioning in adults with insomnia in the first and third months compared to placebo
The Lancet results showed that daridorexant 25 mg and 50 mg improved sleep outcomes, and daridorexant 50 mg also improved daytime function in patients with insomnia with a favorable safety profile
Insomnia is a sleep-wake disorder characterized by difficulty falling asleep and/or maintaining sleep despite adequate sleep opportunities, resulting in daytime-related consequences such as fatigue, difficulty concentrating, and irritability
.
Insomnia is one of the most common sleep-wake disorders, and about 30% of adults worldwide have symptoms of insomnia
If approved, Quviviq would not only be the first dual-acting orexin receptor antagonist in Europe, but also the first insomnia drug to improve daytime function in patients
.
In addition, by periodically reassessing treatment needs, Quviviq can be used for long-term treatment, addressing a key limitation of existing therapies
Jean-Paul Clozel, Managing Director and Chief Executive Officer of Idorsia, reviewed this important CHMP approval, explaining: "The CHMP recommendation is an important milestone for Idorsia and an important step towards bringing new treatment options to patients with insomnia in Europe"
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