Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has announced the enrollment of the first patient in the HORIZON Phase 2 clinical trial evaluating TNX-102 SL 5.6 mg as a first-line monotherapy for adults with major depressive disorder (MDD). This randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of TNX-102 SL in treating MDD, a condition affecting millions worldwide.
The trial is expected to enroll approximately 360 patients across about 30 U.S. sites. The primary endpoint focuses on changes in depression severity after six weeks of treatment, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary endpoints include measures of sleep quality, anxiety, and global clinical improvement. TNX-102 SL is a sublingual formulation of cyclobenzaprine designed to improve sleep quality, which Tonix believes plays a crucial role in the pathophysiology of MDD.
TNX-102 SL is already approved by the U.S. Food and Drug Administration (FDA) under the brand name TONMYA™ for the treatment of fibromyalgia in adults. The therapy has previously shown signals for improving depressive symptoms and subjective sleep quality in earlier clinical studies. Tonix is also developing TNX-102 SL for several other indications, including post-traumatic stress disorder, Long COVID, alcohol use disorder, and agitation in Alzheimer's disease.
The HORIZON trial represents a significant step in expanding the therapeutic use of TNX-102 SL beyond fibromyalgia. If successful, it could offer a new treatment option for MDD patients, particularly those who experience sleep disturbances. The study's results are anticipated to provide valuable insights into the role of sleep quality in depression management and the potential of TNX-102 SL as a first-line monotherapy.
Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments. The company's CNS portfolio includes TONMYA for fibromyalgia, Zembrace® SymTouch® and Tosymra® for acute migraine, and TNX-2900 for Prader-Willi syndrome. Additionally, Tonix is advancing immunology programs such as TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for preventing kidney transplant rejection.
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