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Tonmya FDA Approval Status

FDA Approved: No
Brand name: Tonmya
Generic name: cyclobenzaprine hydrochloride
Previous Name: TNX-102
Company: Tonix Pharmaceuticals Holding Corp.
Treatment for: Post Traumatic Stress Disorder, Fibromyalgia

Tonmya (cyclobenzaprine) is a sublingual formulation of the approved skeletal muscle relaxant cyclobenzaprine in development for the treatment of patients with post-traumatic stress disorder (PTSD) and the management of fibromyalgia.

Development timeline for Tonmya

DateArticle
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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