Tonix Pharmaceuticals to Present TNX-102 SL Fibromyalgia Data at PDDS 2024

Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company, recently presented significant findings at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024) in Rome, Italy. The company showcased data in two oral presentations and a poster presentation, focusing on their proprietary formulation technology and the pharmacokinetic properties of TNX-102 SL (sublingual cyclobenzaprine HCl).

Professor Marino Nebuloni, Director and Qualified Person at Redox Analytical Science Srl, discussed in his presentation the innovative use of mannitol as a eutectic forming agent for sublingual delivery of cyclobenzaprine HCl. This formulation enhances the stability and rapid dissolution of the product, ensuring efficient transmucosal absorption into the bloodstream. The research highlighted the work of Giorgio Reiner and his team at APR Applied Pharma Research S.A. along with Tonix's team.

Chief Executive Officer of Tonix Pharmaceuticals, Dr. Seth Lederman, emphasized the significance of patents based on TNX-102 SL’s eutectic composition. These patents are expected to provide market exclusivity until at least 2034 in various regions including the U.S., E.U., Japan, and China. Dr. Lederman also mentioned that the European Patent Office’s Opposition Division upheld Tonix’s European Patent EP 2 968 992 against an opposition filed by Hexal AG, a subsidiary of Sandoz, and that Hexal AG did not appeal the decision.

Tonix has had two pre-New Drug Application (NDA) meetings with the U.S. Food and Drug Administration (FDA) in 2024. The FDA granted TNX-102 SL a Fast Track designation in July 2024. The submission of the NDA is scheduled for October 2024, with an expected FDA decision date in 2025 under the Prescription Drug User Fee Act (PDUFA).

Dr. Bruce Daugherty, Executive Vice President of Research at Tonix Pharmaceuticals, presented the clinical pharmacology of TNX-102 SL. Designed for sublingual administration, TNX-102 SL aims to improve sleep quality while minimizing daytime drowsiness. Clinical studies revealed that the inclusion of a basifying agent significantly enhanced transmucosal absorption, leading to higher cyclobenzaprine exposure shortly after dosing and reducing levels of its active metabolite, norcyclobenzaprine. This pharmacokinetic profile suggests that TNX-102 SL bypasses first-pass hepatic metabolism, contributing to its clinical efficacy.

Dr. Daugherty also highlighted that TNX-102 SL acts as an antagonist at four different brain receptors, which could explain its role in improving sleep quality. The prevalence and unmet needs in fibromyalgia treatment were also discussed, where TNX-102 SL showed significant improvements in primary and key secondary endpoints in the Phase 3 RESILIENT study compared to placebo.

Siobhan Fogarty, Executive Vice President of Product Development at Tonix, in a poster presentation, discussed the development of in vitro techniques to assess the TNX-102 SL tablet’s characteristics, such as dissolution and disintegration times. These tests are crucial for ensuring consistent product performance and quality during manufacturing.

Dr. Lederman concluded that there remains a significant need for effective fibromyalgia treatments. TNX-102 SL, with its demonstrated broad-spectrum symptom relief and positive results from two Phase 3 studies, is potentially positioned to become the first new treatment option for fibromyalgia patients in 15 years.

Tonix Pharmaceuticals continues to focus on developing therapeutics for central nervous system disorders, rare diseases, and infectious diseases. The company’s development portfolio includes promising candidates like TNX-1300 for cocaine intoxication and TNX-1500 for preventing organ transplant rejection and treating autoimmune diseases.