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

Tonix Pharmaceuticals Receives FDA Guidance To Continue Development of Therapy For Fibromyalgia
The 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 press release, "Our proposed Phase 3 study design is based on our analysis and learnings from the BESTFIT trial results. We are on track to begin the Phase 3 clinical study in this debilitating condition in the second quarter of this year." Tonix Pharmaceuticals is a clinical stage company currently developing first-in-class medicines for disorders of the central nervous system that include fibromyalgia, episodic tension-type headache and post-traumatic stress disorder (PTSD). These are chronic disorders with few treatment options that represent a significant economic burden since they demand constant and continued utilization of healthcare services. TNX-102 SL is the company's lead candidate and has high potential to become the first-line treatment for fibromyalgia and PTSD. Fibromyalgia is chronic condition characterized by widespread pain and
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