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.
Breaking News
Sep 24, 2024
Mrudula Kulkarni
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.