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FAQ: Tonix Pharmaceuticals Enrolls First Patient in Phase 2 Depression Trial for TNX-102 SL
Tonix Pharmaceuticals has enrolled the first patient in a Phase 2 trial evaluating TNX-102 SL as a first-line monotherapy for major depressive disorder. The study aims to assess changes in depression severity, sleep quality, anxiety, and global improvement over six weeks.
The trial evaluates TNX-102 SL 5.6 mg as a first-line monotherapy for adults with major depressive disorder (MDD). It is a randomized, double-blind, placebo-controlled study measuring changes in depression severity, sleep quality, anxiety, and global clinical improvement after six weeks.
Approximately 360 patients will be enrolled at about 30 U.S. sites.
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed to improve sleep quality. It is already FDA-approved as TONMYA for fibromyalgia. The company believes sleep quality plays an important role in MDD, and earlier studies showed signals for improving depressive symptoms and subjective sleep quality.
TNX-102 SL is also being developed for post-traumatic stress disorder, Long COVID, alcohol use disorder, and agitation in Alzheimer’s disease.
The announcement was made by Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) and published via NetworkNewsWire.
The full press release is available at https://nnw.fm/dORql.
Tonix is a commercial-stage biotech focused on CNS and immunology treatments. Its CNS pipeline includes TONMYA for fibromyalgia, TNX-102 SL for MDD and other indications, TNX-2900 for Prader-Willi syndrome, and immunology programs like TNX-4800 for Lyme disease and TNX-1500 for kidney transplant rejection.
Yes, TNX-102 SL (cyclobenzaprine HCl sublingual tablets 2.8 mg) is FDA-approved under the brand name TONMYA for the treatment of fibromyalgia in adults. Its use for other indications is investigational.