FDA accepts filing of daridorexant for insomnia.- Idorsia

Idorsia announced that the FDA has accepted the new drug application (NDA) for review of Idorsia’s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia.The NDA 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 in sleep during the night and, for the first time for an insomnia treatment, 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. The incidence of somnolence was low and did not increase with daridorexant 50 mg compared to placebo. Patients reported no next-morning sleepiness compared to placebo as assessed by the morning visual analogue scale (VAS). These results make daridorexant the first sleep medication to demonstrate an improvement in sleep and daytime functioning, as measured by a newly developed and validated instrument, while keeping a favorable safety profile in adult and elderly patients.