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Tonmya 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

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

Development Status and FDA Approval Process for Tonmya

DateArticle
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
Mar 28, 2017Tonix Pharmaceuticals Enrolls First Participant in Military-Related PTSD Phase 3 Trial of FDA Breakthrough Therapy-Designated TNX-102 SL
Dec 19, 2016Tonix Pharmaceuticals’ PTSD Phase 3-Ready Drug Candidate, TNX-102 SL, Granted Breakthrough Therapy Designation by the FDA
May 13, 2015Tonix Pharmaceuticals Launches Phase 3 Clinical Study of TNX-102 SL in Fibromyalgia
Jun 10, 2014Tonix Pharmaceuticals Receives IND Clearance From FDA for TNX-102 in Post-Traumatic Stress Disorder
Jul 30, 2012Tonix Pharmaceuticals Announces Completion of Clinical Trial of Sublingual TNX-102
Jul  9, 2012Tonix Pharmaceuticals Reports Positive Preclinical Data on Sublingual TNX-102
Apr  5, 2012TONIX Pharmaceuticals Completes Pharmacokinetic Study on New Formulation of TNX-102 for Fibromyalgia

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