For Treasure State Veterans With PTSD, an Attempt to Improve Care

(DGIwire) – Montana, known as “the Treasure State,” claims more veterans per capita than nearly all other states, as well as the highest rate of veteran suicides in the nation, according to the Missoula Current. According to a VA report released in 2017, the suicide rate among Montana veterans is nearly double the national average. In light of this, recent news of clinical research to be conducted in the state is all the more significant.

As reported by The Missoulian, Montana veterans who suffer from posttraumatic stress disorder (PTSD) may be eligible to participate in an ongoing clinical study. In December 2017, Seth Lederman, MD, the CEO of Tonix Pharmaceuticals, joined with representatives from Providence St. Patrick Hospital and the University of Montana to announce the launch of a clinical site in Missoula for a trial of an investigational new drug for PTSD, studying veterans who experienced trauma during military service in 2001 or later. U.S. Senator Jon Tester of Montana was instrumental in helping facilitate the opening of the clinical study site.

“Veterans and their families from the state of Montana, and other states across the country, should be aware that research on PTSD with the goal of validating a new treatment option,” 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. “This study is being conducted at a time when there are no satisfactory approved drug treatments for military-related PTSD.”

The study, called the HONOR study, is a Phase 3 clinical research study sponsored by Tonix Pharmaceuticals. At clinical trial sites across the U.S. including Missoula, a total of 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, 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.

It is 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.

“Tonmya represents a new approach to treating the condition,” Dr. Lederman adds. “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.”

*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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