Tonix Pharmaceuticals Holding Corp. develops treatments for central nervous system syndromes such as fibromyalgia and post-traumatic stress disorder (PTSD). The company's candidates utilize new formulations of cyclobenzaprine, the active ingredient in two FDA-approved prescription muscle relaxants. Tonix recently met with U.S. regulators to discuss and receive guidance for the proposed development of the company's tablet formation of cyclobenzaprine for bedtime use for the treatment of PTSD, and plans to file an Investigational New Drug (NYSE:IND) application for PTSD by the end of the year.
Tonix expects to enter phase 3 trials for its most advanced product candidate, sublingual TNX-102 SL, for the treatment of FM and PTSD in the first quarter of 2013. The company plans to enroll 76 patients for the 12-week study with a primary endpoint of pain reduction. Upon successful completion of this trial, Tonix will move into the confirmatory phase 3 program in Q1 2014.
Thus far, Tonix has been issued three U.S. patents relative to TNX-102 and has also been granted "use of composition" and "composition and methods" patents outside the United States. Additionally, the company has patents pending for treating fatigue using a low dose of cyclobenzaprine, as well as for the treatment of PTSD and depression.
Current FDA-approved treatments for fibromyalgia are Pfizer's (NYSE:PFE) Lyrica; Eli Lilly's (NYSE:LLY) Cymbalta; and Forest Laboratories' (NYSE:FRX) Savella. While these oral formulated drugs are used to treat pain associated with fibromyalgia, there is no drug on the market for improving sleep quality in fibromyalgia patients. Tonix believes its cyclobenzaprine formulation sublingual TNX-102 SL, which is dissolved under the tongue and is absorbed directly into the bloodstream, can reduce pain and improve sleep quality.
For more information visit www.tonixpharma.com
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