Tonix Pharmaceuticals (NASDAQ:TNXP) CEO Seth Lederman joins Proactive's Stephen Gunnion with the news that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-601 ER.
Lederman explains that TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine as a potential treatment for major depressive disorder (MDD).
He said the IND application is an important milestone as the company advances TNX-601 ER into clinical development, with the phase Phase 2 trial in MDD expected to start in the first quarter of 2023.
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