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Tonix Pharmaceuticals Holding Co. which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an End-of-Phase 2/Pre-Phase 3 meeting. These minutes confirmed the FDA’s acceptance of Tonix’s proposed Phase 3 studies and the planned New Drug Application (NDA) data package to support the registration of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD.
As discussed at the End-of-Phase 2/Pre-Phase 3 meeting, and reflected in the final minutes, the FDA indicated that positive results from two adequate, well-controlled Phase 3 efficacy and safety studies and long-term (six- and 12-month) safety exposure studies would provide substantial evidence of efficacy and safety to support the registration of TNX-102 SL, 5.6 mg, for the treatment of PTSD. Tonix expects that the first Phase 3 study will be in military-related PTSD patients and the second Phase 3 study will be in predominantly civilian PTSD patients.
Seth Lederman, M.D., president and chief executive officer of Tonix, said, "We are pleased by the FDA’s response to our completed Phase 2 AtEase study results and encouraged by its agreement on the design of the two Phase 3 studies and our proposed NDA plan. Considering the FDA’s concurrence that the primary endpoint used in the AtEase study will be the same primary endpoint for both upcoming Phase 3 trials, we remain confident in achieving this important milestone. The promising data from the AtEase study supports the potential for TNX-102 SL to be an effective treatment for this large and growing patient population. Importantly, we believe the urgent medical need to treat military-related PTSD also creates the possibility for a Breakthrough Therapy Designation.”
Tonix plans to commence a randomized, double-blind Phase 3 clinical study of TNX-102 SL, 5.6 mg, in military-related PTSD in the first quarter of 2017 and to commence a randomized, double-blind Phase 3 clinical study of TNX-102 SL in predominantly civilian PTSD later in 2017. Tonix expects each of the studies to be conducted in 400 to 500 patients at approximately 35 U.S. centers. In both studies, patients will take either TNX-102 SL, 5.6 mg (2x 2.8 mg), or placebo, daily at bedtime for 12 weeks. Similar to the Phase 2 AtEase study in military-related PTSD, the primary efficacy endpoint of these two Phase 3 studies will be the 12-week mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) between those treated with TNX-102 SL and those receiving placebo.
