After FDA Meeting, Tonix Maps Out Two Phase III PTSD Trials

Tonix Pharmaceuticals reported that the FDA has accepted the company’s proposed Phase III studies and planned NDA data package, following an end-of-Phase 2 meeting on its sublingual tablet for the treatment of post-traumatic stress disorder, TNX-102 SL.

According to Tonix, the FDA indicated that positive results from two adequate, well-controlled Phase III efficacy and safety studies, and six- and 12-month safety exposure data, would provide substantial evidence to support the registration of TNX-102 SL (cyclobenzaprine HCl) for the treatment of PTSD.

Tonix is also developing TNX-102 SL for potential use to treat fibromyalgia, and the FDA has agreed that the same chemistry, manufacturing and controls and nonclinical studies proposal it previously accepted for the fibromyalgia NDA will be applicable for the PTSD NDA.

Tonix plans to begin a Phase III clinical trial of TNX-102 SL in military-related PTSD in the first quarter of next year, and another Phase III study in predominantly civilian PTSD later in 2017. The company expects each study to be conducted in 400 to 500 patients at approximately 35 U.S. centers.