CHMP recommends QUVIVIQ in Europe as a new treatment for adult insomnia patients
pharmafile | February 25, 2022 | News story | Medical Communications |
The CHMP has adopted a positive opinion for the use of QUVIVIQ for the treatment of adult patients with insomnia.
This is the first dual orexin receptor antagonist in the EU for the treatment of adult patients with insomnia, characterised by symptoms present for at least three months and considerable impact on daytime functioning.
This positive opinion is supported by Phase III data, which has been published in The Lancet Neurology. This demonstrated that daridorexant improved nighttime symptoms and daytime functioning in adults with insomnia at months one and three compared to placebo, with a favourable safety profile.
Insomnia disorder is characterised by difficulty initiating or maintaining sleep, which can lead to significant distress and severe impairment in important areas of functioning. This impact on sleep quantity or quality should be present for at least three nights per week, last for at least three months, and should occur despite an adequate opportunity to sleep.
Professor Ingo Fietze, University Hospital Berlin, commented: “The Phase III program with daridorexant was the first to comprehensively measure the impact of pharmacological treatment on all aspects of the condition, including daytime functioning as perceived by patients. Results demonstrated that daridorexant not only significantly improved sleep onset, sleep maintenance and total sleep time in adults with insomnia disorder, but also patients’ daytime functioning, all while maintaining a favorable safety profile.
Having the evidence that treatment can provide benefits on both nighttime symptoms and daytime functioning without the limitations associated with existing insomnia treatments, such as rebound insomnia upon discontinuation of treatment, withdrawal symptoms, risk of dependence, or next-morning residual effects, is going to completely change the treatment landscape for our patients.”
Lina Adams
