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 allodynia (pain caused by a stimulus). The symptoms related to this disease are fatigue, joint stiffness and sleep disturbance, tingling, problems with swallowing and some cognitive dysfunction (the symptoms vary from patient to patient).