By Staff Reports
(DGIwire) – The thrilling crest of an ocean wave may be more than a delight for long-time surfers: it could be therapeutic for military veterans with posttraumatic stress disorder (PTSD). This is the one of the premises that lay behind the founding of Operation Surf, a group dedicated to teaching military veterans the sport. As recently noted on the Sierra Club website and in a recent Netflix documentary, the group has offered “ocean therapy” to those with PTSD as well as those with debilitating physical injuries.
Operation Surf had its origins in the late 1990s when a group of wounded veterans approached a surf instructor based in San Luis Obispo, California, with a desire to learn, notes the Sierra Club. Today, Operation Surf is among a handful of organizations with a similar mission, and a number of experts are studying the science behind ocean therapy.
“While PTSD is an unfortunate outcome of military service that is far too common, the encouraging news is that there are organizations dedicated to finding new treatment approaches to help mitigate the impact of PTSD,” 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. “In addition to various physical activity treatments such as ‘ocean therapy,’ there are clinical studies focused on researching novel treatments that could one day become available if results are positive and approved by the U.S. Food and Drug Administration (FDA).”
There is good news for veterans with PTSD who are interested in learning more about the current PTSD clinical research studies.
One of those studies, for example, is called the HONOR study. This is a Phase 3 clinical research study sponsored by Tonix Pharmaceuticals. At many clinical trial sites across the U.S., about 550 military-related PTSD participants will receive either Tonix’s investigational new drug*, a sublingual (under the tongue) formulation of cyclobenzaprine, or placebo sublingual tablets, taken once-daily at bedtime. Based on the encouraging results in an earlier study with Tonix’s new drug in a population with military-related PTSD, the FDA has designated this investigational new drug a Breakthrough Therapy for the treatment of PTSD. FDA is committed to accelerate the development and approval of a Breakthrough Therapy, which offers potential improvement over existing treatments for a serious disease.
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 for this ongoing research study, TheHONORStudy.com, and 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.
The study is being conducted at a time when there are no satisfactory approved drug treatments for military-related PTSD. Tonix’s 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.
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.
“Veterans who believe they may have PTSD, whether they enjoy athletic pursuits or not, should know researchers are dedicating themselves to the search for novel, effective and safe treatments,” Dr. Lederman adds.
*This investigational new drug has not been approved for any indication.