By Staff Reports
(DGIwire) – For many veterans, the most difficult battles take place after they come home. For some, brain injuries or posttraumatic stress disorder (PTSD) can make the return to civilian life a struggle. There are several simple measures that friends and family members can take to make a difference in the lives of those who served their country and are now feeling PTSD’s effects. Here are four suggestions:
“One way to help veterans who might have PTSD is to encourage them to seek treatment and learn about the potential benefit of participating in the latest clinical research,” says Seth Lederman, MD, the CEO of Tonix Pharmaceuticals, which is developing innovative pharmaceutical and biological products to address public health challenges and significant unmet needs, with its lead program focusing on PTSD. “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).”
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, Tonmya®*, a sublingual (under the tongue) formulation of cyclobenzaprine, or placebo sublingual tablets, taken once-daily at bedtime for 12 weeks. Those who complete the 12-week study and generally fulfill the study requirements are eligible for an additional 12-week study in which all participants receive the investigational new drug, Tonmya, for their PTSD. 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 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, who think they are suffering from PTSD.
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, Tonmya, 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 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.
“Many researchers are searching for novel, effective and safe treatments for PTSD—a realization of great benefit to all those whose lives are being impacted by this condition,” Dr. Lederman adds.
*Tonmya is the FDA conditionally accepted trade name for cyclobenzaprine hydrochloride sublingual tablets and has not been approved for any indication.