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Tonix Pharmaceuticals Announces Data Presentations on TNX-102 SL for Fibromyalgia at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024)
Presentations highlighted the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL (sublingual cyclobenzaprine HCl) Composition and
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Presentations highlighted the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL (sublingual cyclobenzaprine HCl) Composition and methods patents based on the eutectic formulation of TNX-102 SL are expected to provide market exclusivity until at least 2034 in the U.S., E.U., Japan, China and other jurisdictions U.S. FDA New Drug Application (NDA) submission on track for October 2024; Fast Track designation granted by FDA; 2025 PDUFA date for FDA decision on approval expected Results from the confirmatory Phase 3 RESILIENT study of TNX-102 SL demonstrated statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality CHATHAM, N.J., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced data in two oral presentations and a poster presentation at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024), held September 19-21, 2024, in Rome, Italy. Copies of the Company’s oral presentations and poster are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Prof. Marino Nebuloni, Director, Qualified Person, Redox Analytical Science Srl, in an oral presentation titled, “Mannitol as Eutectic Forming Agent for Improved Sublingual Delivery of Cyclobenzaprine HCl,” described the eutectic formation of cyclobenzaprine HCl and mannitol and how it provides a stable product that dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. The work described included studies by Giorgio Reiner and his team at APR Applied Pharma Research S.A. and the team at Tonix. “Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The European Patent Office’s Opposition Divisi...