Tonix receives FDA notice for Tonmya as potential PTSD treatment
Tonix Pharmaceuticals Holding announced that it received the official minutes from the Breakthrough Therapy Type B Clinical Guidance meeting with the U.S. Food and Drug Administration for Tonmya or TNX-102 SL, cyclobenzaprine sublingual tablets, for the treatment of posttraumatic stress disorder, PTSD. The minutes are consistent with the the guidance received at the meeting. As previously announced, the primary endpoint of the RECOVERY Phase 3 trial will be at Week 12, and the Company plans to add an unblinded interim analysis that allows for a potential sample size adjustment. The ongoing RECOVERY trial is enrolling patients with PTSD from civilian or military traumas that occurred within nine years of screening. Seth Lederman, M.D., President and Chief Executive Officer of Tonix commented, "The minutes from our Breakthrough Therapy Clinical Guidance meeting are consistent with the agreement that we previously announced. With more than 50 percent of the current target number of participants enrolled, we look forward to reporting the results of the interim analysis in the first quarter of 2020, followed by topline data in the second quarter of 2020." As previously communicated, the Phase 3 study design changes are being implemented after the FDA indicated the importance of showing persistence of treatment effect at Week 12 in a pivotal study. The primary endpoint will be mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5,CAPS-5, assessed at Week 12. Week 12 was the same timepoint analyzed for the CAPS-5 primary endpoint in the previous Phase 3 HONOR and Phase 2 AtEase studies of Tonmya for PTSD.