Tonix Pharmaceuticals Holding Corp. has announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted Tonmya™ as the trade name for its drug candidate TNX-102 SL, aimed at managing fibromyalgia. This announcement follows the successful completion of two Phase 3 clinical trials, suggesting Tonmya's potential as a new therapeutic option for the chronic condition affecting an estimated 6 to 12 million adults in the United States. The company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024.
Clinical Trial Success
The conditional acceptance of the Tonmya™ trade name is supported by data from two positive Phase 3 trials, RELIEF and RESILIENT. The RESILIENT trial, completed in December 2023, demonstrated highly statistically significant and clinically meaningful results, with Tonmya™ significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Key secondary endpoints, including improvements in sleep quality, fatigue reduction, and overall fibromyalgia symptom management, also showed statistically significant and clinically meaningful results. The RELIEF trial, completed earlier in December 2020, also met its primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.
Mechanism of Action and Potential Benefits
Tonmya™ is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride designed for daily administration at bedtime. Its proposed mechanism involves improving sleep quality in individuals with fibromyalgia. The sublingual administration allows for rapid transmucosal absorption and reduces the production of norcyclobenzaprine, a long half-life active metabolite, by bypassing first-pass hepatic metabolism. Tonmya™ acts as a multifunctional agent with potent binding and antagonist activities at various receptors, including 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic cholinergic receptors.
Management Perspective
"We are very pleased with the FDA’s conditional acceptance of Tonmya as the brand name for TNX-102 SL," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "With this acceptance, we remain excited for what we believe is an important opportunity to offer the first FDA-approved drug for fibromyalgia patients in more than a decade."
Regulatory and Market Exclusivity
Tonix Pharmaceuticals holds several U.S. patents related to Tonmya™, with market exclusivity expected until 2034/2035 upon NDA approval. Additional pending patent applications could extend exclusivity for specific uses, such as treating depressive symptoms and pain in fibromyalgia, potentially until 2041.
About Fibromyalgia
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, and cognitive difficulties. The condition affects millions of adults in the U.S., and there remains a significant unmet need for effective and well-tolerated treatments.
Next Steps
Tonix Pharmaceuticals plans to hold a pre-NDA meeting with the FDA in the first half of 2024 and submit the NDA for Tonmya™ in the second half of the year. If approved, Tonmya™ could provide a novel approach to managing fibromyalgia symptoms and improving the quality of life for affected individuals.
