Benzinga | Aug 24, 2021 07:04AM EDT

Tonix Pharmaceuticals Announces Results Of Pre-IND Meeting With FDA For TNX-102 SL As A Potential Treatment for Long COVID Syndrome; Based On Minutes, Co. Plans To Submit IND In Q4 OD 2021

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it received the official minutes from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-102 SL1 (cyclobenzaprine HCl sublingual tablets) as a potential treatment for Long COVID Syndrome (Long COVID), which is now known officially as Post-Acute Sequelae of COVID-19 (PASC2). Tonix believes the minutes provide a path to agreement on the design of a Phase 2 study and the overall clinical development plan to qualify TNX-102 SL as an indicated treatment for a subset of patients affected by Long COVID. Based on the minutes, the Company is planning to submit the IND in the fourth quarter of 2021 to support a Phase 2 study for the management of a subset of Long COVID patients whose symptoms overlap with fibromyalgia.