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Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA on TNX-601 CR for the Treatment of Major Depressive Disorder
Company Expects to Initiate a Phase 2 Clinical Trial in the Fourth Quarter of 2021, Pending Results of Toxicology Studies CHATHAM, N.J., March 22, 2021 (GLOBE
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Company Expects to Initiate a Phase 2 Clinical Trial in the Fourth Quarter of 2021, Pending Results of Toxicology Studies\nCHATHAM, N.J., March 22, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has received the official minutes from a Type B pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) on its development plan for TNX-601 CR (tianeptine oxalate and naloxone controlled-release) tablet for the treatment of major depressive disorder (MDD). Tonix’s TNX-601 CR is a novel oral formulation which is being developed as a potential treatment for MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (IR) has been available in Europe and many countries in Asia and Latin America for the treatment of depression for more than three decades, first marketed in France in 1989. Based on the official minutes, Tonix expects to submit the IND to conduct a human abuse potential study and meet with FDA’s controlled substances staff (CSS) to reach agreement on the details of the abuse potential study. Pending the results of the human abuse potential study and the results of ongoing nonclinical toxicology studies, Tonix expects to be in a position to initiate a Phase 2 study for the treatment of MDD in the fourth quarter of 2021. “We are pleased with the results of the FDA meeting on developing TNX-601 CR for the treatment of MDD and we look forward to advancing its clinical development,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Tianeptine products have been approved in Europe and other countries around the world and marketed as prescriptions drugs for treating depression for more than 3 decades. We believe that with respect to tianeptine, TNX-601 CR would meet the bioequivalence standard for daily dosing of these immediate release (IR) products. No tianeptine-containing product has been approved by the FDA. TNX-601 CR’s proposed mechanism of action is distinct from any approved antidepressant in the U.S.” “TNX-601 CR is designed for once daily dosing, which is believed to provide an adherence advantage relative to the three times per day dosing...