Tonix Pharmaceuticals is seeking FDA approval for TNX-102 SL for the treatment of fibromyalgia, a chronic condition affecting millions of adults in the U.S. The New Drug Application (NDA) submission is based on positive results from two Phase 3 clinical trials demonstrating statistically significant pain reduction with TNX-102 SL compared to placebo.
TNX-102 SL: A Novel Approach to Fibromyalgia Management
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is a centrally-acting, non-opioid analgesic designed for once-daily bedtime administration. The drug aims to improve sleep quality, reduce pain, and alleviate other fibromyalgia symptoms without causing daytime drowsiness. If approved, TNX-102 SL would be the first new drug for fibromyalgia in over 15 years, addressing a significant unmet need in this patient population. The FDA granted Fast Track designation to TNX-102 SL in July 2024, potentially expediting the review process.
Seth Lederman, M.D., CEO of Tonix, stated, "With our recent NDA submission to the U.S. Food and Drug Administration (FDA), 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 U.S. suffering from fibromyalgia."
Clinical Trial Data Supporting NDA Submission
The NDA submission is supported by data from the Phase 3 RELIEF and RESILIENT trials. The RESILIENT study, for example, met its primary endpoint, demonstrating a significant reduction in daily pain compared to placebo (p-value=0.00005). Participants treated with TNX-102 SL also showed statistically significant improvements in key secondary endpoints, including sleep quality, fatigue, and overall fibromyalgia symptoms and function. The drug was well-tolerated, with an adverse event profile comparable to prior studies.
Advancing Mpox Vaccine Candidate TNX-801
In addition to TNX-102 SL, Tonix is also developing TNX-801, a potential vaccine to protect against mpox disease and smallpox. New data presented in September and October 2024 demonstrated tolerability and no evidence of spreading to blood or tissues, even at high doses, in immunocompromised animals. TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge.
Financial and Corporate Updates
Tonix reported $28.2 million in cash and cash equivalents as of September 30, 2024. The company also received its first payment from the Defense Threat Reduction Agency (DTRA) as part of a contract to develop broad-spectrum antiviral agents. Research and development expenses for the third quarter of 2024 were $9.1 million, compared to $21.0 million for the same period in 2023.
