Tonix Pharmaceuticals Announces FDA Acceptance of New Drug Application for Fibromyalgia Treatment

Tonix Pharmaceuticals Holding Corp. recently disclosed in an 8-K filing a significant development regarding its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The NDA pertains to TNX-102 SL, a cyclobenzaprine HCl sublingual tablet intended for the management of fibromyalgia.

On December 17, 2024, the company unveiled that the FDA accepted the filing of the NDA for TNX-102 SL. The FDA is projected to designate a Prescription Drug User Fee Act (PDUFA) target action date in a Day 74 Letter, which will also include whether Priority Review has been granted for the NDA.

TNX-102 SL, characterized as a non-opioid, centrally-acting analgesic, was bestowed with Fast Track designation for fibromyalgia by the FDA in July 2024, aimed at expediting the review of essential new drugs addressing serious conditions and unmet medical needs.

Dr. Seth Lederman, Chief Executive Officer of Tonix Pharmaceuticals, expressed the company’s commitment to delivering a groundbreaking medicine for fibromyalgia management. He underscored the longstanding need for an innovative drug in the fibromyalgia community, which has been unaddressed for over 15 years. Analysis conducted by Tonix showed that fibromyalgia patients were more likely to be prescribed addictive opioids 18 months post-diagnosis than all three FDA-approved drugs combined.

The NDA submission is underpinned by data from two pivotal Phase 3 studies of TNX-102 SL for fibromyalgia management. These studies demonstrated significant pain reduction compared to a placebo, with TNX-102 SL showing good tolerability. Notably, the trials indicated that most treatment-related adverse events were mild and temporary, showcasing promising safety profiles.

Fibromyalgia, affecting over 10 million adults in the U.S., predominantly women, is a chronic pain disorder arising from heightened sensory and pain signaling within the central nervous system. Symptoms include widespread pain, sleep disturbances, fatigue, and cognitive impairments, among others.

TNX-102 SL stands as a potent candidate to address fibromyalgia’s unmet needs. Its mechanism of action targets non-restorative sleep, a hallmark feature of fibromyalgia, with the potential to transform treatment in a field that has witnessed scant innovations in over a decade. Tonix remains dedicated to navigating the NDA review process diligently, with the possibility of bringing TNX-102 SL to market by 2025.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Tonix Pharmaceuticals’s 8K filing here.

About Tonix Pharmaceuticals

Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company, focuses on developing, discovering, commercializing, and licensing therapeutics to treat and prevent human disease and alleviate suffering. It markets Zembrace SymTouch and Tosymra for the treatment of acute migraine with or without aura in adults.