FDA Accepts Tonix’s NDA For TNX-102 SL, A Non-Opioid Fibromyalgia Treatment

Tonix Pharmaceuticals Holding Corp. has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) at a 5.6 mg dose. This non-opioid, centrally-acting analgesic is designed to treat fibromyalgia. The FDA is expected to assign a target decision date under the Prescription Drug User Fee Act (PDUFA) in a Day 74 Letter, which will also confirm if the application qualifies for Priority Review. TNX-102 SL received Fast Track designation from the FDA in July 2024, a program aimed at expediting the approval process for treatments addressing serious conditions with unmet medical needs.

Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, said in a statement, “The FDA’s acceptance of our NDA represents another step forward as we pursue our goal of delivering the first member of a new class of medicines for the management of fibromyalgia, a condition affecting over 10 million adults in the U.S.The fibromyalgia community, comprised of patients and their families and support groups, has been waiting for a new drug for over 15 years. Analysis of insurance claims in the U.S., commissioned by Tonix, have shown that 18 months after diagnosis, fibromyalgia patients were more likely to be prescribed addictive opioids than all three of the FDA-approved drugs combined.”

Dr. Lederman continued, “We look forward to working closely with the FDA throughout the NDA review period with the goal of bringing TNX-102 SL to the market to address the significant unmet needs of the fibromyalgia community as quickly as possible. Furthermore, this is an important milestone as we advance our commercial preparations in anticipation of a potential approval in 2025 with an accomplished commercial leadership team already in place, supporting our marketed products Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.”

The NDA is supported by results from two 14-week Phase 3 clinical trials examining TNX-102 SL's safety and effectiveness as a bedtime treatment for fibromyalgia. The first trial, RELIEF, completed in December 2020, achieved its primary goal of significantly reducing daily pain compared to a placebo (p=0.010). Similarly, the confirmatory RESILIENT trial, completed in December 2023 which also met its primary endpoint, demonstrated a significant reduction in daily pain versus placebo. Both trials showed that the medication was generally well-tolerated, with no new safety concerns identified. 

The most frequently reported side effect was mild, short-term numbness in the mouth or tongue linked to the site of administration. This side effect was temporary, rarely severe, and rarely caused participants to drop out of the studies (only one person per trial). Other adverse events, excluding those related to COVID-19, occurred at rates below 4%. Tonix believes the submitted data from these two potent and well-controlled studies provide strong evidence to support FDA approval of TNX-102 SL for managing fibromyalgia.