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FDA Clearance Supports Start of Phase 2 Trial of TNX-102 SL for Agitation in Alzheimer’s Patients
The U.S. Food and Drug Administration (FDA) approved Tonix Pharmaceuticals’ investigational new drug (IND) application to support the start of a Phase 2 trial of TNX-102 SL in Alzheimer’s patients with agitation. In December 2016, the treatment candidate was granted breakthrough therapy status — a process designated to accelerate the development of promising medications for serious