Tonix Pharmaceuticals Holding CorpEnrollment of first patient in Phase 2 study for TNX-102 SL in MDD, a new indication for an already approved drug.

Tonix Pharmaceuticals has enrolled the first patient in its potentially pivotal Phase 2 HORIZON study evaluating TNX-102 SL as a first-line monotherapy for adults with major depressive disorder. The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 360 patients across about 30 U.S. sites, with the primary endpoint being the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Week 6. TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride, was approved by the FDA in August 2025 and launched commercially as TONMYA for fibromyalgia. The company is now exploring its potential in MDD, targeting disturbed sleep quality through antagonism at four neuronal receptors.
Tonix Pharmaceuticals Holding CorpEnrollment of first patient in Phase 2 study for TNX-102 SL in MDD, a new indication for an already approved drug.