Tonix Pharmaceuticals Receives FDA Guidance To Continue Development of Therapy For Fibromyalgia

Tonix Pharmaceuticals Receives FDA Guidance To Continue Development of Therapy For Fibromyalgia
shutterstock_190838585The Tonix Pharmaceuticals Holding Corp. received written guidance from the United States Food and Drug Administration (FDA) on the company's Phase 3 clinical trials for the TNX-102 SL in fibromyalgia. Seth Lederman, M.D., Chief Executive Officer and president of Tonix Pharmaceuticals, said in a press release: "Getting this confirmation from the FDA – particularly its acceptance of the 30 percent responder analysis as the primary outcome measure — represents a clear step forward in our ongoing development of TNX-102 SL in fibromyalgia." The 30 percent responder analysis is defined as an improvement in pain, as measured by the number of subjects who achieve at least a 30 percent improvement in their pain scores. In the Phase 2b BESTFIT study, TNX-102 SL demonstrated an improvement in the 30 percent assessment of the respondents, a statistically significant improvement. Dr. Seth Lederman added in a
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