Tonix Pharmaceuticals Holding Corp. recently revealed in an 8-K filing with the U.S. Securities and Exchange Commission that the U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date for August 15, 2025, to make a decision regarding the marketing approval of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia.
The company’s press release attached to the filing indicated that Tonix Pharmaceuticals is looking forward to continued collaboration with the FDA throughout the review process leading up to the PDUFA goal date in August 2025. The company believes that TNX-102 SL has the potential to be an innovative medicine addressing the needs of over 10 million adults in the U.S. suffering from fibromyalgia.
TNX-102 SL, designated as a non-opioid, centrally acting analgesic, aims to potentially become the first of its kind in a new class of drugs for fibromyalgia, marking a significant advancement in treatment options for the condition. The drug candidate has previously been granted Fast Track designation by the FDA in July 2024.
The NDA submission for TNX-102 SL is supported by results from two Phase 3 studies demonstrating its efficacy and safety for the management of fibromyalgia. Both trials showed TNX-102 SL to be well tolerated, with significant pain reduction compared to a placebo. The most common treatment-related adverse event observed in both studies was temporary tongue or mouth numbness at the administration site.
Fibromyalgia is a prevalent chronic pain condition predominantly affecting women in the U.S. with symptoms including widespread pain, fatigue, and cognitive dysfunction. The approval of TNX-102 SL could significantly impact the management of this debilitating condition by introducing an alternative treatment option after more than 15 years of limited advancements in drug therapy.
Investors are advised to exercise caution and refrain from placing undue reliance on forward-looking statements contained in this report. Such statements are subject to a range of risks and uncertainties that could lead to material differences between anticipated and actual outcomes. Tonix Pharmaceuticals underscored that the information presented in the report is accurate as of its publication date and is not indicative of future developments without explicit reference in subsequent filings.
Overall, Tonix Pharmaceuticals’ progress with TNX-102 SL for fibromyalgia shines a spotlight on the company’s commitment to addressing unmet medical needs in the field of pain management and presents a significant opportunity for patients and investors alike.
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.
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