Idorsia Pharmaceuticals US Inc. announced today 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).
RADNOR, Pa., May 10, 2023 /PRNewswire/ --Idorsia Pharmaceuticals US Inc. announced today 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 Important Safety Information QUVIVIQ is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia). Do not take QUVIVIQ if you fall asleep often at unexpected times (narcolepsy). QUVIVIQ may cause serious side effects, including:
QUVIVIQ is a federally controlled substance because it can be abused or lead to dependence. Before taking QUVIVIQ, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
What should I avoid while taking QUVIVIQ?
QUVIVIQ may cause other serious side effects, including:
The most common side effects of QUVIVIQ are headache and sleepiness. These are not the only side effects of QUVIVIQ. Call your doctor for advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-108 Notes to the editor About Insomnia Insomnia is a condition of overactive brain activity during sleep, and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. Insomnia is the most common sleep disorder, affecting more than 25 million adults in the US.6 Poor quality or insufficient sleep can affect many aspects of the daily lives of people with trouble sleeping including the ability to concentrate, mood and energy levels.2 In the long-term, insomnia is associated with numerous serious health conditions, such as psychiatric disorders, cardiovascular disease, type 2 diabetes, substance abuse and dementia.3,4,5 About PTSD While patients suffering from PTSD all exhibit some element of the cardinal features as defined by the DSM-5, there is significant heterogeneity in clinical presentation. Certain symptoms may be more prominent in some patients than others, and most patients have at least 1 additional psychiatric comorbidity such as insomnia, depressive disorders, anxiety disorders, or substance use disorders. PTSD symptoms can persist for years or decades after the traumatic event; only one-third of patients recovered at the 1-year follow-up and one-third remained symptomatic 10 years later.8 PTSD is associated with poor social support, higher healthcare utilization, and may be associated with increased mortality.9 References
About Idorsia US About Idorsia Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1'000 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contact Global Investors & Media The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
SOURCE Idorsia Pharmaceuticals U.S. | ||
Company Codes: Swiss:IDIA |
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