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
|Jul 6, 2017||Tonix 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, 2017||Tonix Pharmaceuticals Presented Retrospective Analyses of Treatment Response and Remission to TNX-102 SL in a Phase 2 Military-Related PTSD Study|
|Mar 28, 2017||Tonix Pharmaceuticals Enrolls First Participant in Military-Related PTSD Phase 3 Trial of FDA Breakthrough Therapy-Designated TNX-102 SL|
|Dec 19, 2016||Tonix Pharmaceuticals’ PTSD Phase 3-Ready Drug Candidate, TNX-102 SL, Granted Breakthrough Therapy Designation by the FDA|
|May 13, 2015||Tonix Pharmaceuticals Launches Phase 3 Clinical Study of TNX-102 SL in Fibromyalgia|
|Jun 10, 2014||Tonix Pharmaceuticals Receives IND Clearance From FDA for TNX-102 in Post-Traumatic Stress Disorder|
|Jul 30, 2012||Tonix Pharmaceuticals Announces Completion of Clinical Trial of Sublingual TNX-102|
|Jul 9, 2012||Tonix Pharmaceuticals Reports Positive Preclinical Data on Sublingual TNX-102|
|Apr 5, 2012||TONIX Pharmaceuticals Completes Pharmacokinetic Study on New Formulation of TNX-102 for Fibromyalgia|
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