Bringing Military Veterans’ Stress to the Big Screen and the Search for Better Treatment Options

OFF THE WIRE
Bringing Military Veterans’ Stress to the Big Screen and the Search for Better Treatment Options http://ow.ly/WzKT30hks8N #PTSD #HonorStudy
(DGIwire) – Military service members—including those with post-traumatic stress disorder (PTSD)—are often silent about their experiences when they get back home. An American film released in October 2017, Thank You For Your Service, aimed to give them a voice. As reported by CNN, the drama is based on the book of the same name by journalist David Finkel and tells the story of a group of soldiers struggling to reintegrate into civilian life after returning from tours in Iraq.

Actor Miles Teller portrays a sergeant coping with both the stresses of family life and haunting combat memories. Writer and director Jason Hall, who also wrote the screenplay for American Sniper, told CNN he specifically set out to bring the civilian population closer to understanding what some veterans have gone through. In real life as in Hollywood, dramatic efforts are being made on behalf of veterans with PTSD.

“Giving the general population a better sense of the unique stresses experienced by veterans—which can include the ordeal of PTSD—is a valuable goal,” says Seth Lederman, MD, the CEO of Tonix Pharmaceuticals, which is developing innovative pharmaceutical and biological products to address public health challenges, with its lead program focusing on PTSD.

As the movie highlights the challenges veterans face, it is important to note that there are efforts to ensure that current and future veterans are well taken care of when they return home, especially for conditions such as PTSD.

One of those efforts is through clinical research to find new treatments. Those who were in the military and think they may be affected by PTSD may consider speaking with their doctor about clinical research studies that are currently enrolling new participants. For example, the HONOR study is a Phase 3 clinical research study sponsored by Tonix Pharmaceuticals that will enroll about 550 military-related PTSD participants at approximately 45 sites across the U.S. Those enrolled will receive either an investigational new drug*, a patented sublingual transmucosal formulation of cyclobenzaprine, or placebo sublingual tablets, once-daily at bedtime.

Based on the encouraging results in an earlier study with this investigational new drug in a population with military-related PTSD, the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Tonix’s investigational new drug for the treatment of PTSD. FDA is committed to accelerating the development and approval of a Breakthrough Therapy that offers potential improvement over existing treatments for a serious disease. Currently there are no satisfactory approved drug treatments for military-related PTSD. The investigational new drug used in the HONOR study represents a new approach to treating the condition. While symptoms of PTSD may improve or worsen while taking part in this research study, participation will provide information about the study drug, a new approach to treating PTSD that might benefit others with the condition in the future.

What are the next steps for interested veterans? To see if a veteran is pre-qualified to participate in this research study, they should access the study website, TheHONORStudy.com, and can also learn more about it at https://clinicaltrials.gov/ct2/show/NCT03062540. The HONOR study is open to veterans or those currently serving in any branch of the military or as a military contractor.

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.

“On-screen and off-screen, in daily life and on the forefront of research, initiatives to help veterans with PTSD will contribute to a brighter tomorrow for them and their families,” adds Dr. Lederman.

*This investigational new drug has not been approved for any indication.