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Tonix Pharmaceuticals Highlights Phase 3 Results and Patents for TNX-102 SL

Tonix shares Phase 3 success for TNX-102 SL in fibromyalgia and outlines its path to FDA approval by 2025.

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  • Sep 24, 2024

  • Mrudula Kulkarni

Tonix Pharmaceuticals Highlights Phase 3 Results and Patents for TNX-102 SL

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) presented data on its promising fibromyalgia drug, TNX-102 SL, at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024) in Rome. The company highlighted TNX-102 SL’s innovative eutectic formulation, which enables rapid sublingual absorption. Patents for this formulation extend exclusivity until 2034 in key markets like the U.S., E.U., and Japan.

The company also discussed results from the Phase 3 RESILIENT study, showing significant improvements in fibromyalgia pain, sleep quality, and other symptoms. These findings support Tonix’s New Drug Application (NDA) submission to the U.S. FDA in October 2024, with a potential approval decision by 2025. TNX-102 SL has already received Fast Track designation, underlining the urgency of this treatment for fibromyalgia patients.

 

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