Tonix expert examines ways to improve sleep problems and provide relief to people with PTSD

Sleep problems—a common condition among military personnel—may increase the risk of developing post-traumatic stress disorder (PTSD) and other mental health conditions. So concludes a team of researchers at the RAND Corporation, whose study—published on RAND's website—was recently described in national media outlets.

The RAND report surveyed nearly 2,000 married service members from all branches of the military to assess how well they were sleeping. About a third of service members reported getting five hours or less of sleep per night. Moreover, about half of service members had sleep problems and about 33 percent reported being fatigued at least three or four times a week. There was also a link between sleep problems and an increased risk of PTSD, depression, poorer physical health and lower operational readiness, the researchers said.

This study supports the efforts of Seth Lederman, MD, the co-founder and CEO of Tonix Pharmaceuticals Holding Corp., who is engaged in a quest to tackle the challenge of finding an effective PTSD treatment. Lederman believes the path to improved treatment lies in addressing sleep quality. There are only two FDA-approved products for PTSD, but clinical trials have failed to show a consistent effect in males or in military populations, and their use can be limited by side effects. Other anti-anxiety and sleep medicines are often prescribed, but those medicines are not ideal due to their short-term efficacy and safety concerns. There is clearly an unmet need for a non-habit forming, safe, pharmaceutical option.

Sleep disturbances are core symptoms of PTSD. These disturbances are classified as "re-experiencing" symptoms when they manifest as distressing dreams and nightmares and as "hyperarousal" symptoms when insomnia or restless sleep are present. Poor sleep quality after a trauma is linked to the onset of PTSD and correlates with depression, substance abuse and suicide.

At Tonix, Lederman and his team are overseeing the development of TNX-102 SL, a small, rapidly disintegrating sublingual (under-the-tongue) tablet consisting of 2.8 mg of cyclobenzaprine for daily bedtime use. Tonix is developing TNX-102 SL as a potential treatment for PTSD that targets mechanisms that are associated with disturbed sleep and nightmares. The active ingredient of TNX-102 SL has an extensive history of clinical use and is one of the most widely prescribed medications in the U.S. as an acute treatment for muscle spasm.

A Phase 2 trial of TNX-102 SL in PTSD (the AtEase study) was initiated in January 2015. This randomized, double blind, placebo-controlled trial will enroll 220 individuals with combat-related PTSD at approximately 25 U.S. clinical sites. The primary efficacy endpoint is the difference in the Clinician-Administered PTSD Scale (CAPS) scores between TNX-102 SL 2.8 mg and placebo. As supported by prior clinical studies, TNX-102 SL may have the potential to improve disturbed sleep and provide relief to the symptoms experienced by people with PTSD.