FDA approves Tonix's Tonmya for fibromyalgia; first new therapy in over 15 years

Tonix Pharmaceuticals Holding Corp.

Tonmya (cyclobenzaprine HCl sublingual tablets) approved for adults with fibromyalgia; Q4 2025 commercial launch expected.
Approval based on two Phase 3 trials (~1,000 patients) showing significant pain reduction vs placebo at 14 weeks.
Over 10 million U.S. adults affected; Tonmya is first-in-class non-opioid bedtime analgesic.
Company to host webcast August 18 at 8:30 AM ET to discuss approval.

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