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FDA Approves Tonix's Tonmya for Fibromyalgia, First New Drug in 15 Years

FDA Approves Tonix's Tonmya for Fibromyalgia, First New Drug in 15 Years
business • 8/15/2025

Tonmya, a non-opioid sublingual tablet, showed significant pain reduction in 1,000+ patient trials. Targets 10M+ US adults with fibromyalgia. Commercial launch set for Q4 2025.

Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia 08/15/2025 - 03:44 PM Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years Fibro... [22316 chars]