First new fibromyalgia drug in 15 years, Tonmya (cyclobenzaprine HCl) gains FDA approval and hits pharmacy shelves
Sanatate
From Hanson Wade Group - Non-Opioid Pain Therapeutics Summit Dec 5 2025 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. The medication is now commercially available by prescription in U.S. pharmacies, offering new hope to the roughly 10 million American adults
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