The U.S. Military Takes a Positive Step to Address Post-Traumatic Stress

By Staff Reports

(DGIwire) – The U.S. military is ramping up its efforts to address one of the most serious health issues impacting veterans: posttraumatic stress disorder (PTSD). According to the U.S. Department of Veterans Affairs, 11 to 20 percent of veterans who served in Afghanistan and Iraq as part of Operations Iraqi Freedom, Enduring Freedom, and New Dawn (OIF/OEF/OND) experience PTSD in a given year.

The urgent need for novel treatment was the focus of a June 2017 State of the Science Summit called “Pathophysiology of Post-Traumatic Stress Disorder: Rethinking Drug Targets,” which involved 140 invited participants including many leading researchers in PTSD. Split into working groups, they pooled insights on a range of topics such as promising mechanisms of action and drugs in development, desirable attributes for PTSD therapeutics and more.

“The summit generated insights on the development of more effective therapeutics for PTSD,” says Seth Lederman, MD, the CEO of Tonix Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing pharmaceutical products to treat serious neuropsychiatric conditions and biological products to improve biodefense, with its lead program focusing on PTSD. “It was largely agreed that treatment should address sleep quality, have a proven mechanism of action, and be both effective and enduring. It was also emphasized that PTSD drugs need to be safe with minimal side effects, be easy to take, and have low potential for abuse. Repurposing of existing drugs for the treatment of PTSD treatment was also deemed potentially useful, particularly because of the advantage of an established safety profile. There is substantial evidence that these goals are worth pursuing.”

In addition to the government’s enhanced focus on moving the state of care forward, there is also good news for veterans with PTSD who are interested in learning more about the potential benefits of enrolling in currently available clinical research studies in PTSD. One such study, called the HONOR study, is a Phase 3 clinical research study sponsored by Tonix Pharmaceuticals. At about 40 clinical trial sites across the U.S., approximately 550 military-related PTSD participants will receive either Tonix’s investigational new drug, Tonmya®*, a sublingual (under the tongue) formulation of cyclobenzaprine, or placebo sublingual tablets, taken once-daily at bedtime for 12 weeks. Based on the encouraging results in an earlier study with Tonmya in military-related PTSD, the FDA has designated Tonmya a Breakthrough Therapy for the treatment of PTSD. FDA is committed to accelerate the development and approval of a Breakthrough Therapy, which may offer potential improvement over existing treatments for a serious disease.

What are the next steps? To see if a veteran is pre-qualified to participate in this ongoing research study, they should access the study website, TheHONORStudy.com, for additional information. The HONOR study is open to veterans or those currently serving in any branch of the military, or as a military contractor, who experienced traumatic events during military service since 2001. An in-person screening to determine eligibility for the study involves an evaluation for PTSD symptoms, a medical history and physical exam, and laboratory tests to assess physical health.

The HONOR study is being conducted at a time when there are no satisfactory approved drug treatments for military-related PTSD. Tonix’s investigational new drug, Tonmya, used in the HONOR study represents a new approach to treating this condition. While symptoms of PTSD may improve or worsen while taking part in this research study, participation will provide information about the study drug that might benefit others with the condition in the future.

It is also important to note that Tonix has taken steps to ensure the privacy of participants in the study. To protect the participants’ identities and confidential medical information, the study organizers have obtained a Certificate of Confidentiality from the U.S. Department of Health & Human Services to ensure participants’ identities are shielded from all persons not connected with this clinical research project. The holder of this Certificate of Confidentiality may not be compelled in any Federal, state, or local civil, criminal, administrative, legislative or other proceedings to identify the research participants.

“In light of last year’s State of the Science Summit and ongoing clinical studies, veterans and their families whose lives have been affected by PTSD should feel encouraged that advances are being actively sought with significant progress being made,” Dr. Lederman adds.

*Tonmya is the FDA conditionally accepted trade name for cyclobenzaprine hydrochloride sublingual tablets and has not been approved for any indication.

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