Tonix Showcased Tonmya™ for Fibromyalgia at EULAR 2024

Tonix Pharmaceuticals, Inc., a biopharmaceutical company, has revealed promising data from a Phase 3 trial of their drug, Tonmya™ (TNX-102 SL, sublingual cyclobenzaprine HCl), aimed at treating fibromyalgia. The data was presented at the Annual European Congress of Rheumatology (EULAR) 2024, which took place in Vienna, Austria.

The Phase 3 RESILIENT study demonstrated that treatment with Tonmya significantly reduced daily pain in participants with fibromyalgia compared to a placebo, achieving a p-value of 0.00005. This indicates a statistically significant improvement. Furthermore, Tonmya showed significant improvements across six key secondary endpoints, which included enhancements in sleep quality, reduced fatigue, better patient global ratings, and overall fibromyalgia symptoms and function. These results suggest that Tonmya could offer broad syndromal improvement for patients suffering from fibromyalgia, a condition characterized by widespread musculoskeletal pain, fatigue, and other symptoms.

The trial also included pre-specified exploratory analyses that revealed Tonmya's positive effects on depressive symptoms, as measured by the Beck Depression Inventory, and on female sexual function, as gauged by the Changes in Sexual Function Questionnaire.

Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, emphasized the significant impact fibromyalgia has on patients' daily lives, quality of life, and overall functionality. He expressed optimism about Tonmya's potential to address multiple symptoms of fibromyalgia, such as pain, sleep disturbances, fatigue, cognitive dysfunction, and depression. This could position Tonmya as a comprehensive treatment option for fibromyalgia, possibly the first new therapy for this condition in over a decade.

Tonix Pharmaceuticals is on schedule to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the latter half of 2024. This submission is for the approval of Tonmya for managing fibromyalgia, bolstered by the statistically significant results from two Phase 3 studies.

Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing and commercializing innovative therapies to address central nervous system (CNS) disorders, rare diseases, infectious diseases, and other therapeutic areas. Their development portfolio includes various product candidates, such as TNX-1300, a biologic for treating cocaine intoxication currently in Phase 2 development, and TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) for preventing allograft rejection and treating autoimmune diseases.

Additionally, Tonix has commercial products under its subsidiary, Tonix Medicines, which markets Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for acute migraine treatment in adults.

While Tonix's product candidates are still investigational and have not received approval for any indication, the company remains committed to advancing its pipeline and bringing new therapeutic options to patients in need.