RADNOR, PA — Idorsia Pharmaceuticals US Inc. recently announced its support of a clinical study sponsored by the U.S. Department of Defense (DOD) to develop new therapies to treat Posttraumatic Stress Disorder (PTSD).
The Phase 2 multi-center, multi-arm, randomized, placebo-controlled, double-blind, adaptive platform clinical trial will evaluate the safety, tolerability, and efficacy of potential therapeutic interventions in active-duty U.S. service members and veterans with PTSD. This clinical trial will include QUVIVIQ® (daridorexant) CIV, a medicine approved by the FDA for the treatment of adults with difficulty falling or staying asleep (insomnia), and at least two other FDA-approved medications for the treatment of depression, all of which will be studied under an Investigational New Drug application for the treatment of PTSD. QUVIVIQ is a dual orexin receptor antagonist (DORA) that was approved in 2022 in the United States and the European Union, and it is the only FDA-approved insomnia medication being evaluated in this study.
The clinical trial is expected to enroll its first subject in Q2 2023, and the QUVIVIQ arm of the study is forecast to run for approximately three years. Study endpoints for each medication will be measured after twelve weeks of treatment and compared to pooled placebo, with the primary endpoints being validated endpoints that measure PTSD symptom severity, and secondary endpoints measuring insomnia and other medical conditions. Complete trial details are available here: https://www.clinicaltrials.gov/ct2/show/NCT05422612.
“This innovative clinical trial and public-private partnership addresses the need for safe and effective therapies to treat PTSD in our current and former servicemen and women, as well as the general population,” said Dr. Kimberly del Carmen, the DOD’s PTSD Drug Treatment Program Product Manager at the U.S. Army Medical Materiel Development Activity (USAMMDA) at Fort Detrick, Maryland. USAMMDA is working on behalf of the Defense Health Agency to administer the trial. “We’ll efficiently test multiple potential treatments for PTSD and significantly contribute to the development of new safe and effective therapies.”
In the U.S., QUVIVIQ was approved by the FDA in January 2022 for the treatment of adults who have trouble falling asleep or staying asleep (insomnia).1 It is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptide orexin, which is thought to turn down overactive wake signaling, in contrast to many other insomnia medications that cause a sedative effect on the central nervous system. Idorsia is supporting this clinical trial by providing study drug and placebo to DOD as well as access to the validated measurement tool, Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).
For more information about QUVIVIQ, see the Full Prescribing Information and Medication Guide
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