Idorsia (SIX: IDIA) has announced positive top-line results from its Phase 2 dose-finding study evaluating 10, 25, and 50 mg doses of daridorexant—the company’s dual orexin receptor antagonist (DORA)—in pediatric patients with insomnia disorder.
The study confirmed, for the first time, the excellent safety and tolerability profile of daridorexant in pediatric patients as young as ten. Even at the recommended adult dose of 50 mg, daridorexant’s safety profile remained similar to placebo, with no adverse events denoting drug abuse during treatment and no indication of withdrawal symptoms upon discontinuation.
In a statement, Martine Clozel, MD, pediatrician, CSO and head of research of Indorsia, commented, “The data are remarkable. We are not only helping young patients and their families—who urgently need evidence-based treatments when children suffer from chronic insomnia—but we are also seeing new signals that the orexin system may play an even more important role in neurodevelopmental disorders than previously understood. I cannot wait to present the data to the scientific community.”
