Development of TNX 601 ER1,a once-daily formulation of tianeptine for depression is ended following phase II trial results
Tonix’s once-daily formulation of tianeptine, widely used to treat depression in Europe, failed to improve depression severity in a Phase II study and will be discontinued
The reformulated version of the older antidepressant tianeptine failed a Phase II study in major depressive disorder (MDD). Tonix said it was ending development of the drug.
TNX-601 ER, an extended-release formulation of tianeptine was optimized for once-daily dosing but missed the primary endpoint of change from baseline in depression severity. Tonix provided no numerical data from the top-line readout; the drug did not achieve clinical or statistical significance on the Montgomery-Asberg Depression Rating Scale (MADRS) after six weeks of treatment with a daily 39.4mg dose in the 132-patient, placebo-controlled UPLIFT study.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins