Tonix launches TONMYA as first new fibromyalgia treatment in 15 years

Tonix Pharmaceuticals Holding Corp.

TONMYA (cyclobenzaprine HCl sublingual tablets) now available by prescription nationwide.
FDA approved Aug 15, 2025; first non-opioid once-daily bedtime analgesic for fibromyalgia.
Phase 3 trials (nearly 1,000 patients) showed significant pain reduction vs placebo at 14 weeks.
Most common side effects: oral hypoesthesia, somnolence, dry mouth.

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