- Tonix Pharmaceuticals (TNXP +1.0%) announces that it has received the official minutes from a Type B pre-investigational new drug (IND) meeting with the U.S. FDA on its development plan for TNX-601 CR (tianeptine oxalate and naloxone controlled-release) tablet for the treatment of major depressive disorder (MDD).
- The company said, based on the minutes of the meeting, it 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.
- Tonix expects to be in a position to initiate a Phase 2 study for the treatment of MDD in the fourth quarter of 2021.
- 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.