Under the direction of Dr. Jeffrey Ross, Medical Director and Board-Certified Psychiatrist, Great Lakes Clinical Trials was honored to be one of 25 U.S. clinical trial sites which conducted a dose-finding clinical study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in military-related PTSD (The "AtEase Study").
According to the press release.:
- The goal of the AtEase Study was to evaluate the potential clinical benefit of using TNX- 102 SL to treat military-related PTSD at a dose of 2.8 mg or 5.6 mg.
Although the 2.8 mg dose trended in the direction of a therapeutic effect, it did not reach statistical significance on the primary endpoint. In contrast, the 5.6 mg dose had a therapeutic effect.
Seth Lederman, M.D., president and chief executive officer of Tonix, stated,
“TNX-102 SL 5.6 mg taken sublingually (under the tongue) at bedtime demonstrated efficacy and safety for the treatment of military-related PTSD compared to placebo. We are pleased to have established a dose-response relationship of TNX-102 SL in this Phase 2 PTSD study and identified the 5.6 mg dose as appropriate for Phase 3 development."
The AtEase Study was Phase 2 clinical trial. Tonix Pharmaceuticals will now work with the Food and Drug Administration (FDA) to develop a Phase 3 research program to support the registration of TNX-102 SL 5.6 mg for the treatment of PTSD. Dr. Ross and Great Lakes Clinical Trials hope to be involved in that program as well. At the conclusion of the Phase 3 program and if the program is successful, we may soon see TNX-102 available via prescription to the general public.