Nov 26, 2019: Tonix Pharmaceuticals, a clinical-stage biopharmaceutical company announced that from the Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA) it received the official minutes from the Breakthrough Therapy Type B for Tonmya®* (or TNX-102 SL, cyclobenzaprine sublingual tablets) for the treatment of posttraumatic stress disorder (PTSD).
The minutes from our Breakthrough Therapy Clinical Guidance meeting are consistent with the agreement that we 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, With more than 50 percent of the current target number of participants enrolled, results of the report of the interim analysis will be in the first quarter of 2020. https://fda.einnews.com/pr_news/503308754/tonix-pharmaceuticals-announces-receipt-of-fda-official-minutes-from-breakthrough-therapy-type-b-clinical-guidance-meeting-for-tonmya-as-a-potential
