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Tonix Pharmaceuticals Announces Development of TNX-601 ER, a Potential Abuse Deterrent, Extended-Release Formulation of Tianeptine Oxalate for the Treatment of Major Depressive Disorder
Naloxone-Free Formulation of Tianeptine is an Extended-Release Tablet that Includes Inactive Ingredients and Compression Properties Designed to Confer Abuse
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Naloxone-Free Formulation of Tianeptine is an Extended-Release Tablet that Includes Inactive Ingredients and Compression Properties Designed to Confer Abuse Deterrence Once-Daily Tablet Formulation of Tianeptine is Bioequivalent to the Three Times a Day Antidepressant Marketed in Europe for Over 30 years Tianeptine’s Enhancement of Neuroplasticity in Animal Models of Stress Implies a Distinct Indirect Glutamatergic Mechanism of Action Relative to Antidepressants Marketed in the U.S. Planning to Initiate Enrollment in U.S. Phase 2 Study in First Quarter 2023, Pending FDA Clearance of IND CHATHAM, N.J., July 11, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced development of TNX-601 ER (tianeptine oxalate extended-release tablets), a naloxone-free formulation of TNX-601 designed to confer abuse-deterrence, for the treatment of major depressive disorder (MDD)1. Tonix expects to initiate a Phase 2 study of TNX-601 ER for the treatment of MDD in the first quarter of 2023, pending U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application. Tonix’s TNX-601 ER is being developed as a treatment for MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (IR) tablets have been available in Europe and many countries in Asia and Latin America for the treatment of MDD over the more than three decades since it was first marketed in France in 1989. No tianeptine-containing product has been approved by the FDA. The proposed mechanism of action of TNX-601 ER is distinct from traditional monoaminergic antidepressants in the U.S. In addition to its glutamatergic properties central to its antidepressant effect, tianeptine has weak µ-opioid receptor agonist properties and has been linked to illicit misuse at much higher doses than those reported to be effective in the treatment of MDD2. Previously, Tonix was developing a naloxone-containing tablet, TNX-601 CR (tianeptine oxalate and naloxone controlled-release) for MDD, that was designed to mitigate the risk of parenteral abuse. “TNX-601 ER is a naloxone-free tablet formulated with inactive ingredients that we believe will make the tablet more difficult to ...