Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA on TNX-601 CR for the Treatment of Major Depressive Disorder
Tonixs 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.
- Tonixs 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.
- 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.
- We believe that with respect to tianeptine, TNX-601 CR would meet the bioequivalence standard for daily dosing of these immediate release (IR) products.
- Given tianetptines unique metabolic pathway, we believe that TNX-601 CR has a reduced risk of drug-drug interactions compared to SSRIs5.