Publication in Psychiatry Research showing activity of bedtime TNX 102 SL on PTSD symptoms and sleep quality in military-related PTSD at four weeks of therapy.- Tonix Pharma
Tonix Pharmaceuticals Holding Corp. announced the publication of a research paper in the Journal Psychiatry Research . The article titled, “A Phase III, Randomized, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Bedtime Sublingual Cyclobenzaprine (TNX 102 SL) in Military-Related Posttraumatic Stress Disorder,” by Parmenter, et al. found that bedtime TNX 102 SL treatment is well-tolerated and showed nominal improvement in PTSD severity and sleep quality measures in the first four weeks in military-related posttraumatic stress disorder (PTSD).
The Company believes these findings suggest a potential role for short-term bedtime TNX 102 SL treatment in the immediate aftermath of traumatic events.
The data support the U.S. Department of Defense (DoD)-funded Phase II investigator-initiated OASIS trial to evaluate bedtime TNX 102 SL2 in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and PTSD.
The IND supporting the OASIS trial was recently cleared, and the trial is expected to begin enrolling in the second quarter. The trial is sponsored by The University of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from DoD. In the OASIS study, 14 days of bedtime TNX 102 SL 5.6 mg will be tested in the immediate aftermath of motor vehicle collision. The study will test the potential for TNX 102 SL treatment initiated within 24 hours of index trauma to target trauma-related sleep disturbance and other ASR symptoms to facilitate recovery from ASR and to prevent PTSD.
"There is an urgent need for interventions to reduce rates of ASD and PTSD in the immediate aftermath of trauma,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe the results in the published paper suggest that bedtime TNX 102 SL has short-term activity on improving PTSD symptom severity and sleep quality in military-related PTSD. Poor sleep after trauma is a risk factor for progressing from ASD to PTSD. Therefore, poor sleep is not only a symptom of ASR, ASD and PTSD, but also a potential target of therapy.”
In addition to the Phase III HONOR study for fibromyalgia described in the published article, Tonix has also studied TNX 102 SL in a Phase II (‘AtEase’) trial in military PTSD and in a Phase III (‘RECOVERY’) trial in civilian PTSD. Both studies were performed with the primary endpoint of CAPS-5 improvement at Week 12. AtEase compared bedtime TNX 102 SL at two doses (2.8 mg & 5.6 mg) and placebo. RECOVERY compared TNX 102 SL 5.6 mg and placebo. Neither study reached statistical significance on the primary endpoint.
See- Parmenter ME, et al. Psychiatry Research. 2024. 334: 115764. https://doi.org/10.1016/j.psychres.2024.115764.
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