Daridorexant filed with EU for insomnia.- Idorsia

Idorsia Ltd announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for daridorexant, Idorsia's investigational dual orexin receptor antagonist, for the treatment of adult patients with insomnia.The MAA includes data from a comprehensive clinical and non-clinical development program. In the Phase III registration program, daridorexant showed statistically significant and clinically meaningful improvements not only in sleep duration, but also in patient-perceived sleep quantity and quality, and, for the first time for an insomnia treatment, an improvement in daytime functioning, which were sustained over time. The Phase III program provided a deep understanding of the safety and tolerability profile of daridorexant. Adverse reactions reported with a frequency of at least 2% in daridorexant-treated patients and greater (at least 1%) than in placebo-treated patients in 3-month efficacy trials were headache, somnolence, fatigue, dizziness, and nausea. Patients reported no next-morning sleepiness compared to placebo as assessed by the morning visual analogue scale (VAS). The incidence of somnolence was low and did not increase with daridorexant 50 mg compared to placebo.