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Tonix Pharmaceuticals Announces Completion of Long-Term Exposure Studies in Participants with PTSD to Evaluate the Tolerability of TNX-102 SL 5.6 mg
Company Expects this Long-Term Safety Exposure Data to Satisfy Long-Term Exposure Requirements for Potential New Drug Applications for TNX-102 SL for PTSD and
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Company Expects this Long-Term Safety Exposure Data to Satisfy Long-Term Exposure Requirements for Potential New Drug Applications for TNX-102 SL for PTSD and Fibromyalgia\nNEW YORK, Oct. 03, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced Tonix has completed collecting the required long-term safety exposure data of TNX-102 SL 5.6 mg in participants with posttraumatic stress disorder (PTSD) to support the TNX-102 SL New Drug Application (NDA) for the treatment of PTSD. The data provide Tonix with exposure data of daily dosing of TNX-102 SL 5.6 mg for at least 12 months in more than 50 individuals, and daily dosing of TNX-102 SL 5.6 mg for at least 6 months in more than 100 individuals. The data was collected in open label extension (OLE) studies of the PTSD program.\n “We are pleased to have reached this important milestone,” said Seth Lederman, M.D., President and Chief Executive Officer. “PTSD is a serious chronic psychiatric condition, and, based on our agreement with the FDA regarding the requirements for the long-term safety exposure data needed to support an NDA submission, we believe that Tonix now has sufficient long-term exposure data to meet the requirement and support the NDA. Importantly, TNX-102 SL 5.6 mg is the same drug candidate in Phase 3 development for the treatment of fibromyalgia and we believe the long- term exposure data from the PTSD program may also support the fibromyalgia NDA.” About Tonix Pharmaceuticals Holding Corp. Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat psychiatric, pain and addiction conditions, to improve biodefense through potential medical counter-measures, to treat transplant rejection and to treat gastric and pancreatic cancers. Tonix’s lead program is for the development of Tonmya* (TNX-102 SL), which is in Phase 3 development as a bedtime treatment for PTSD. Tonix is also developing TNX-102 SL as a bedtime treatment for fibromyalgia, agitation in Alzheimer’s disease and alcohol use disorder, under separate Investigational New Drug applications (INDs) to support potential pivotal efficacy studies. The fibromyalgia program is in Phase 3 development, the agitation in Alzheimer’s program is Phase...