Tonix enrolls first patient in depression trial
- Tonix Pharmaceuticals (NASDAQ:TNXP) enrolled the first patient in its Phase 2 HORIZON study for major depressive disorder.
- The trial will include about 360 patients across roughly 30 U.S. sites, measuring changes in MADRS score at six weeks.
- TNX-102 SL (TONMYA) is FDA-approved for fibromyalgia and is being tested here as first-line monotherapy.
Tonix Pharmaceuticals (NASDAQ:TNXP) said it enrolled the first patient in HORIZON, a Phase 2, randomized, double-blind, placebo-controlled study of TNX-102 SL 5.6 mg for adults with major depressive disorder.
The trial will last six weeks in the U.S., enrolling approximately 360 participants across about 30 clinical sites, with efficacy measured by changes in Montgomery–Åsberg Depression Rating Scale (MADRS) scores at Week 6.
TNX-102 SL, marketed as TONMYA, is already FDA-approved for treating fibromyalgia in adults, providing safety and regulatory precedent for use in additional indications.
The HORIZON study is intended to evaluate TNX-102 SL as a first-line monotherapy, assessing both efficacy and tolerability in a controlled major depressive disorder population.
Tonix continues to explore TNX-102 SL in multiple indications, leveraging existing clinical and regulatory experience to accelerate development timelines.
The company aims to expand the clinical program for TNX-102 SL beyond fibromyalgia while gathering pivotal data for potential registration in major depressive disorder.
