Tonix Pharmaceuticals Holding Corp. (TNXP) on Tuesday said it received official minutes from the pre-IND meeting with FDA to develop TNX-102 SL as a potential treatment for Long COVID Syndrome.
Based on the minutes, the company plans to submit the investigational new drug application in the fourth quarter of 2021 for a Phase 2 study of TNX-102 SL in a subset of Long COVID patients whose symptoms overlap with fibromyalgia.
TNX-102 SL, a patented sublingual tablet formulation of cyclobenzaprine hydrochloride is in mid-Phase 3 development for the treatment of fibromyalgia.
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