First new fibromyalgia drug in 15 years, Tonmya (cyclobenzaprine HCl) gains FDA approval and hits pharmacy shelves

In a milestone moment for chronic pain management, Tonix Pharmaceuticals announced on August 15, 2025, that its novel sublingual therapy Tonmya has received approval from the U.S. Food and Drug Administration (FDA) – marking the first new drug for Fibromyalgia in more than 15 years.