Tonix Pharmaceuticals has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TNX-102 SL, a sublingual tablet designed to treat fibromyalgia. The submission is based on positive results from two Phase 3 clinical trials demonstrating significant improvements in sleep quality and pain reduction in fibromyalgia patients.
TNX-102 SL: A Novel Approach to Fibromyalgia Treatment
TNX-102 SL is a non-opioid, centrally acting analgesic intended for bedtime use. It features a eutectic formulation of cyclobenzaprine HCl and mannitol, designed for rapid dissolution and efficient transmucosal absorption. This formulation aims to improve sleep quality and reduce the risk of daytime somnolence, addressing key symptoms of fibromyalgia.
Clinical Trial Data
The NDA submission is supported by data from two Phase 3 studies, RELIEF and RESILIENT. The RESILIENT study met its pre-specified primary endpoint, showing a statistically significant reduction in daily pain compared to placebo (p<0.05). Furthermore, the study demonstrated broad syndromal benefits, with statistically significant improvements in all six pre-specified key secondary endpoints, including sleep quality, fatigue reduction, patient global ratings, and overall fibromyalgia symptoms and function. TNX-102 SL was well-tolerated, with an adverse event profile comparable to prior studies and no new safety signals observed.
The RELIEF trial, completed earlier, also demonstrated statistically significant reductions in daily pain compared to placebo.
Addressing an Unmet Need
Fibromyalgia affects over 10 million adults in the U.S., predominantly women. The condition is characterized by widespread pain, non-restorative sleep, fatigue, and cognitive dysfunction, significantly impairing daily activities and quality of life. While there are currently three FDA-approved medications for fibromyalgia, a significant unmet need remains for new and effective treatments.
"With our recent NDA submission to the US Food and Drug Administration, Tonix is excited about the potential of TNX-102 SL to become the first new drug treatment option in more than 15 years for the roughly 10 million adults in the US suffering from fibromyalgia," said Seth Lederman, MD, chief executive officer of Tonix.
Regulatory Pathway and Future Expectations
The FDA granted TNX-102 SL Fast Track designation in the third quarter of 2024, which is intended to expedite the review of new drugs that address unmet needs for serious conditions. If the NDA filing is accepted in December, a decision on the marketing approval of TNX-102 SL for fibromyalgia is expected in 2025.
Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, noted the limitations of existing fibromyalgia treatments, such as gabapentinoids and SNRIs. If approved, TNX-102 SL would be the first tricyclic class medication for fibromyalgia, offering a new treatment avenue for patients dissatisfied with current options.
Potential Impact on Long COVID
Tonix has also noted that, based on the new definition of long COVID by the US National Academies of Sciences, Engineering, and Medicine, fibromyalgia is a "diagnosable condition" in people experiencing long COVID. The company believes that diagnosing fibromyalgia in long COVID patients will increase the potential market for TNX-102 SL following approval.
