Tonix Receives FDA Clearance for Phase 2 Trial of TNX-102 SL for Major Depressive Disorder.

Tonix Pharmaceuticals Holdings has received FDA clearance to launch a Phase 2 trial for its drug TNX-102 SL to treat major depressive disorder (MDD) in adults. The trial, called HORIZON, will enroll 360 adults across 30 US clinical sites and compare TNX-102 SL against placebo. Tonix aims to advance TNX-102 SL as a novel therapeutic option for the substantial unmet medical need in MDD, which affects over 21 million adults in the US annually.