On August 15, 2025, Tonix Pharmaceuticals Holding Corp. (TNXP) announced that the U.S. Food and Drug Administration (FDA) approved Tonmya (cyclobenzaprine HCl sublingual tablet) for the treatment of fibromyalgia. Tonmya is the first FDA approved therapy for fibromyalgia in over 15 years. The approval was based in part on data from two double blind, placebo controlled Phase 3 trials of nearly 1,000 patients in total that showed Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. The company did not announce the wholesale acquisition cost (WAC) while it continues to perform market analysis. We anticipate Tonmya becoming available in the fourth quarter of 2025 with a sales force of approximately 90 representatives.
