The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for daridorexant, an investigational dual orexin receptor, for the treatment of insomnia in adult patients.
The NDA is supported by data from a comprehensive development program that includes 2 pivotal phase 3 studies (ClinicalTrials.gov: NCT03545191 [Study 1] and NCT03575104 [Study 2]). The multicenter, double-blind, placebo-controlled phase 3 studies evaluated the efficacy and safety of daridorexant in 1854 patients 18 years of age and older with insomnia. Patients were randomly assigned to receive daridorexant or placebo orally once daily in the evening for 3 months.
Results from Study 1 and Study 2 showed that daridorexant achieved statistically significant and clinically meaningful improvements in sleep onset and maintenance from baseline to months 1 and 3 compared with placebo. Patients treated with daridorexant also demonstrated a significant improvement in daytime performance at months 1 and 3.
The safety profile of daridorexant was found to be comparable to placebo. The most common treatment-emergent adverse events included nasopharyngitis, headache, somnolence and fatigue. Moreover, daridorexant was not associated with next morning residual effects, rebound insomnia, or withdrawal symptoms upon discontinuation.
If approved, the Company expects to launch in the US in the first half of 2022.
FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia. [press release]. Allschwil, Switzerland: Idorsia Ltd; March 10, 2021.