Tonix Pharma Begins Phase 2 Study Of TNX-201 In Episodic Tension-type Headache

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) announced it has begun randomizing patients into a Phase 2 clinical study of TNX-201 (dexisometheptene mucate) in episodic tension-type headache. The study is expected to enroll approximately 200 patients. Tonix plans to report top-line results from the study in the fourth quarter of 2015.

The randomized, double-blind, placebo-controlled, proof-of-concept Phase 2 study will evaluate the efficacy and safety of a single 140 mg dose of TNX-201 versus placebo for the treatment of a single tension-type headache. In addition to the primary efficacy endpoint of pain-free at two hours post-dose as recommended by the U.S. FDA for a prospective confirmatory tension headache study, the study will also assess efficacy according to a variety of measure.