Tonix Drops Fibromyalgia, Will Pursue PTSD Claim With Cyclobenzaprine Formulation

Failing to meet the primary endpoint of a Phase III trial of TNX-102 SL in fibromyalgia, cash-limited Tonix decides to focus on developing the drug for PTSD – which it thinks is the path of least regulatory resistance. A pair of pivotal trials is slated to commence in 2017.

With limited cash flow, Tonix Pharmaceuticals Holding Corp. is shelving development of its sublingual formulation of the muscle relaxer cyclobenzaprine in fibromyalgia to focus on post-traumatic stress disorder, because of greater clarity in terms of the regulatory path forward.

On Sept. 6, the New York-based firm reported that TNX-102 SL, a sublingual formulation of cyclobenzaprine designed to evade first-pass...

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