Recognizing and Treating PTSD: Key Points to Consider

(DGIwire) – It’s normal to feel fear and anxiety during and after a traumatic event. But people with posttraumatic stress disorder (PTSD) can find it difficult or impossible to recover from the powerful emotions and body symptoms that arise in response, which sometimes may take months or even years to develop after the events that caused them. What types of behaviors should families and friends look for in an individual who might be experiencing PTSD? According to the University of California-Berkeley School of Public Health, these symptoms can include:

  • Re-experiencing events (in the forms of memories, nightmares, and flashbacks) that they can’t seem to escape
  • Withdrawing from places or events that remind them of their experience, or shutting themselves off from contact with others because of fear and anxiety
  • Experiencing worsening depression or feelings of guilt or anxiety
  • Becoming angry, edgy or easily startled, often without knowing why
  • Developing negative thoughts about themselves or the world around them

As with other psychiatric conditions, multiple approaches exist for the treatment of PTSD. As Berkeley reports, these can include medications, individual or group psychotherapy, and cognitive and/or behavioral therapy. Working with a trained professional can result in a tailored treatment plan. Researchers continue to seek new and more effective therapies for PTSD.

“As many of those with PTSD and their families continue to seek better options for treatment, it is important to realize there are ongoing research programs investigating  novel approaches to help mitigate the impact of this condition,” 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. “As daunting as it can be to experience this condition firsthand, or to live with someone who does, it can also be reassuring to learn about the extent of work and recent progress in exploring potential new treatment options.”

There is good news for veterans with PTSD who are interested in learning more about the currently available clinical research studies in PTSD. One such study, called the HONOR study, is a 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 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 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.

“The search is ongoing for novel, effective and safe treatments for veterans who believe they may have PTSD,” Dr. Lederman adds. “But each day we learn more and get closer to that goal.”

*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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