Tonix Pharmaceuticals Announces Results of Pre-IND Meeting

Today, a clinical-stage biopharmaceutical company, Tonix Pharmaceuticals Holding Corp., announced to have received the official minutes of meeting from a Type B pre-investigational new drug (IND) meeting the united states Food and Drug Administration (FDA). The meeting was regarding the company’s development plan for the TNX-601 CR tablet for the treatment of major depressive disorder (MDD).

Toxin’s TNX-601 CR is a novel oral formulation that is being developed as a potential cure for MDD, neurocognitive dysfunction associated with corticosteroid use, and posttraumatic stress disorder. In Europe and many parts of Asia and Latin America, Tianeptine sodium has been available for treating depression for more than three decades. It was first marketed in 1989 in France.

Based on the official minutes of the meeting, Tonix Pharmaceuticals expects to submit the IND to conduct a human abuse potential study. The company also expects to meet the FDA’s controlled substances staff to reach an agreement related to the possible abuse study details. Tonix awaits the results of the ongoing nonclinical toxicology studies and the human abuse potential study. The experts say they will be able to initiate the second phase of the research for treating MDD in the fourth quarter of 2021.

Chief Executive Officer and President of Tonix Pharmaceuticals, Seth Lederman, M.D., said, “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. TNX-601 CR’s proposed mechanism of action is distinct from any approved antidepressant in the U.S.”