Tonix Pharmaceuticals, Set To File An NDA For Tonmya For The Management Of Fibromyalgia, Assuming Approval By The FDA In 2H 2025

With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.

The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA - Tonix's Tonmya and one from another U.S. company - there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.