FDA clears Tonix IND in major depressive disorder

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The FDA approved Tonix Pharmaceuticals’ (NASDAQ:TNXP) IND application to support a Phase 2 clinical trial with TNX-601 ER, a once-daily formulation of tianeptine as a potential treatment for major depressive disorder (MDD).

Tianeptine is a new molecular entity in the U.S. that is being developed under the 505(b)(1) pathway.

The potentially pivotal Phase 2 six-week double-blind, placebo-controlled study is expected to randomize 300 male and female subjects aged 18 to 65 years into two treatment arms across approximately 30 clinical trial sites in the U.S.

The study is expected to have a single unblinded interim analysis for sample size re-estimation when the study has results of the first 50% of efficacy evaluable patients.

“We expect to initiate the Phase 2 trial in MDD in the first quarter of 2023, with the potential for additional future indications in post-traumatic stress disorder and neurocognitive dysfunction from corticosteroids,” Seth Lederman, M.D. and CEO of Tonix, said in a statement.