FDA Approves Tonix Pharma's Tonmya For Treatment Of Fibromyalgia In Adults

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Holding Corp.

TNXP

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Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years

Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women

Two Pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated

Commercial availability of Tonmya is expected in the fourth quarter

Company to host webcast and conference call on Monday August 18, 2025 at 8:30 AM ET

CHATHAM, N.J., Aug. 15, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years.

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