Idorsia Ltd reports positive results from the first pivotal Phase 3 study investigating 25 and 50 mg doses of its dual orexin receptor antagonist, daridorexant, in adult and elderly patients with insomnia. The findings will be presented at Virtual SLEEP 2020.
The abstract entitled “A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Polysomnography Study to Assess Efficacy and Safety of Daridorexant in Adult and Elderly Insomnia Patients” will be presented as an oral presentation by Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital, and will be available on demand to registered attendees of SLEEP 2020 as part of the late-breaking program.
The Phase 3 program design will also be presented as a poster entitled “0521 – Daridorexant (ACT-541468), a dual orexin receptor antagonist for the treatment of insomnia disorder: double blind, randomized, Phase 3 studies for efficacy and safety in adult and elderly patients.”
In April and July 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia.
Its Phase 3 registration program comprises two confirmatory studies of 3-month duration, together with a long-term extension study. Both pivotal studies are complete, having enrolled around 1,850 patients with insomnia at over 160 sites across 18 countries. As insomnia often presents later in life, around 40% of the recruited population was aged 65 years or older. The confirmatory multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography studies investigated three doses of daridorexant (10 mg, 25 mg, and 50 mg) on sleep and daytime functioning parameters, objectively in a sleep lab by polysomnography and subjectively with a daily patient diary at home.
The impact of insomnia on patients’ daytime functioning was measured daily using the sleepiness domain score from the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) a Patient Reported Outcome (PRO) instrument, validated according to the US Food and Drug Administration (FDA) Guidance for Industry. 806 patients decided to continue treatment in the ongoing 40-week extension study which will measure the effect of all three doses vs. placebo, generating data for long-term treatment of insomnia.