Tonix Pharmaceuticals (NASDAQ: TNXP) announced that the U.S. FDA has accepted its New Drug Application (“NDA”) for TNX-102 SL, a 5.6 mg non-opioid analgesic for managing fibromyalgia, following its Fast Track designation in July 2024. The NDA is supported by two successful Phase 3 trials, RELIEF and RESILIENT, where TNX-102 SL met its primary endpoint of significantly reducing daily pain compared to placebo. The drug was generally well-tolerated, with the most common adverse event being temporary tongue or mouth numbness. Tonix aims to address the unmet needs of over 10 million U.S. adults with fibromyalgia, as existing treatments have left patients at risk for opioid prescriptions. The company anticipates potential approval in 2025, with commercial preparations underway alongside its current migraine treatments, Zembrace® SymTouch® and Tosymra®.
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About Tonix Pharmaceuticals Holding Corp.
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s priority is to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) this month for TNX-102 SL, a product candidate for which two statistically significant phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL was generally well tolerated in the phase 3 program. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix recently announced that the U.S. Department of Defense (“DoD”), Defense Threat Reduction Agency (“DTRA”) awarded it a contract for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Maryland. The company’s Good Manufacturing Practice (“GMP”)-capable advanced manufacturing facility in Dartmouth, Maryland, was purpose-built to manufacture TNX-801, and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (“CNS”) disorders. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, the company’s commercial subsidiary, markets Zembrace(R) SymTouch(R) (sumatriptan injection) 3 mg and Tosymra(R)(sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. For more information about the company, please visit www.TonixPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP
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