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TNX-102 FDA Approval Status

FDA Approved: No
Brand name: TNX-102
Generic name: cyclobenzaprine hydrochloride
Company: Tonix Pharmaceuticals Holding Corp.
Treatment for: Fibromyalgia

TNX-102 (cyclobenzaprine) is a sublingual formulation of the approved skeletal muscle relaxant cyclobenzaprine in development for the treatment of pain associated with fibromyalgia.

Development timeline for TNX-102

DateArticle
Dec 23, 2024Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia
Dec 17, 2024Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia
Oct 16, 2024Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)
Dec 20, 2023Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia
Apr 24, 2020Tonix Pharmaceuticals Achieves 50 Percent Enrollment in Phase 3 RELIEF Study of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for Management of Fibromyalgia
Jul  6, 2017Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya as Proposed Brand Name for TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for the Treatment of PTSD
May 30, 2017Tonix Pharmaceuticals Presented Retrospective Analyses of Treatment Response and Remission to TNX-102 SL in a Phase 2 Military-Related PTSD Study
Jun 10, 2014Tonix Pharmaceuticals Receives IND Clearance From FDA for TNX-102 in Post-Traumatic Stress Disorder

Further information

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