FDA To Review Tonix’s TNX-102 SL For Fibromyalgia By August 2025

Today, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) has set a target date for the Prescription Drug User Fee Act (PDUFA) on August 15, 2025. The date is decided to determine the marketing approval for TNX-102 SL, a sublingual tablet formulation of cyclobenzaprine HCl, for treating fibromyalgia. This non-opioid, centrally-acting pain reliever is designed as a bedtime treatment for fibromyalgia, a chronic pain condition that predominantly affects women. The FDA’s acceptance of the New Drug Application (NDA) is backed by results from two robust 14-week Phase 3 clinical trials: RELIEF and RESILIENT. 

Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, said in a statement, “We look forward to working closely with the FDA throughout the review period in advance of the August 15, 2025, PDUFA goal date. We believe that TNX-102 SL has the potential to be the first member of a new class of medicines for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. Data from our pivotal Phase 3 trials support that TNX-102 SL can provide fibromyalgia patients with a significant reduction in pain with favourable tolerability, helping to address the significant unmet need in this community.”

He also said, “TNX-102 SL was previously granted Fast Track designation for fibromyalgia by the FDA in July 2024. Fast Track is designed to expedite the FDA review of important new drugs to treat serious conditions and meet unmet medical needs. This recognition from the FDA confirms that the Agency recognises the significant unmet needs of the fibromyalgia community, who have been waiting for a new drug for over 15 years.”

Both were double-masked, randomised, and placebo-controlled, evaluating the safety and efficacy of TNX-102 SL. The RELIEF trial, completed in December 2020, demonstrated that TNX-102 SL 5.6 mg significantly reduced daily pain compared to placebo. Similarly, the confirmatory RESILIENT study, completed in December 2023, showed even more decisive results, considerably reducing daily pain.

In both trials, TNX-102 SL was generally well tolerated. The most common side effect was mild, temporary numbness of the tongue or mouth at the administration site. It resolved on its own and was rarely severe enough to cause participants to leave the study. Systemic adverse events were uncommon, with all rates under 4%, excluding those related to COVID-19.

Tonix is confident that the NDA submission includes sufficient safety and efficacy data from these well-controlled studies. This will support FDA approval, marking a significant step forward for fibromyalgia patients seeking non-opioid treatment options.