By Staff Reports
(DGIwire) – What do Hurt Locker, American Sniper and Goodbye Christopher Robin have in common? All three movies involve posttraumatic stress disorder (PTSD) among military men as one of their themes. Hurt Locker follows the day-to-day travails of three soldiers in an explosive ordnance detachment in Iraq; American Sniper, based on a real-life American sharpshooter deployed to Iraq, portrays both the experiencing and overcoming of PTSD-related symptoms; and Goodbye Christopher Robin suggests that A. A. Milne, creator of Winnie the Pooh, experienced PTSD following his service in World War I.
Those are just a few examples of Hollywood’s portrayal of this serious condition in recent years. In Shutter Island, Leonard DiCaprio’s character experiences PTSD following World War II; in Aloha and Silver Linings Playbook, Bradley Cooper plays characters with the condition, as he did in American Sniper; and in Independence Day, Randy Quaid’s character does as well. And most recently in Thank You For Your Service, the lives of several veterans with PTSD trying to adjust and re-integrate into civilian life post-deployment in Iraq are chronicled.
“Mainstream Hollywood movies have proven to be an effective vehicle for raising awareness about this serious condition, which affects many of those who come home from serving their country,” 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. “After learning more about the challenges these brave men and women face, those whose lives have been impacted and their families may wish to explore research into novel treatments occurring today. These treatments are aiming to address some of the major symptoms of PTSD including recurring nightmares, flashbacks, extreme irritability, estrangement from others, and severe sleep disturbance.”
There is good news for veterans with PTSD who are interested in learning more about the potential benefit of enrolling in currently available clinical research studies in PTSD. One such study, called the HONOR study, is a large-scale 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, those interested 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 will be evaluated for symptoms of PTSD.
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.
“Anyone whose interest in PTSD has been sparked by portrayals in popular culture—especially if they know someone who might be experiencing its symptoms—may be inspired to share the details about the latest PTSD clinical research activities, i.e., the HONOR study,” Dr. Lederman adds.
*Tonmya is the FDA conditionally accepted trade name for cyclobenzaprine hydrochloride sublingual tablets and has not been approved for any indication.