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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.

Mrudula Kulkarni
By Mrudula Kulkarni
Managing Editor - Pharma Now
Sep 24, 2024Updated Jun 26, 2025 · 2 min read
Tonix Pharmaceuticals Highlights Phase 3 Results and Patents for TNX-102 SL
https://www.sapnamed.com/pain-conditions/fibromyalgia/
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Reviewed by Mrudula Kulkarni, Managing Editor - Pharma Now

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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Mrudula Kulkarni
Written by
Mrudula Kulkarni
Managing Editor - Pharma Now

My international experience as a researcher in Taiwan for three years has equipped me with a global perspective, enabling me to create content that resonates with an international audience.



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