By Staff Reports
(DGIwire) – Tossing and turning under the covers at night is no fun for anybody. But when a person experiences an extended bout of insomnia or poor sleep quality, there may be something more to the problem.
This issue may be especially pressing for veterans. Sleep problems—in particular poor sleep quality and nightmares—are frequently some of the more troubling aspects of posttraumatic stress disorder (PTSD), reports the National Center for PTSD, a division of the U.S. Department of Veterans Affairs. Insomnia was among the commonly reported PTSD symptoms in a survey of veterans from Afghanistan and Iraq that was published in the journal Military Medicine and cited by the National Center for PTSD.
“Although everyone suffers from poor sleep quality from time to time, when it is experienced by a veteran over an extended period, it could be a sign of a more serious condition,” 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. “Because poor sleep quality has been reported to be one of the major symptoms of PTSD**, this could be a concern. In fact, there is currently research focused on the potential of a new treatment to improve PTSD through therapeutic effects on sleep quality.”
There is good news for veterans with PTSD who are interested in learning more about the potential benefits of enrolling in 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 ongoing research study, they 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 experienced traumatic events during military service since 2001. An in-person screening to determine eligibility for the study involves an evaluation for PTSD symptoms, a medical history and physical exam, and laboratory tests to assess physical health.
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.
“When sleep quality is a concern for veterans, a thorough medical examination is a good idea—and if a diagnosis of PTSD is rendered, it is worth considering the option of participation in clinical research studies investigating potential new therapies,” Dr. Lederman adds.
*Tonmya is the FDA conditionally accepted trade name for cyclobenzaprine hydrochloride sublingual tablets and has not been approved for any indication.
**Onton JA, Matthews SC, Kang DY, Coleman TP. In-Home Sleep Recordings in Military Veterans With Posttraumatic Stress Disorder Reveal Less REM and Deep Sleep <1 Hz. Front Hum Neurosci. 2018;12:196.