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Tonix Pharmaceuticals Announces Program to Develop TNX-102 SL for the Treatment of Long COVID Syndrome, also Known as Post-Acute Sequelae of COVID-19 (PASC)
Long COVID Symptoms of Pain, Sleep Disturbance, Fatigue and Brain Fog Overlap with Symptoms of Fibromyalgia, for which TNX-102 SL is in Mid-Phase 3
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Long COVID Symptoms of Pain, Sleep Disturbance, Fatigue and Brain Fog Overlap with Symptoms of Fibromyalgia, for which TNX-102 SL is in Mid-Phase 3 Development Condition Afflicts More Than 30 Percent of Patients Post Infection with SARS-CoV-2, the Virus that Causes COVID-19 Pre-IND Meeting with FDA Scheduled for Q3 2021 CHATHAM, N.J., June 21, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it plans to develop TNX-102 SL (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 (PASC1). Tonix plans to meet with the U.S. Food and Drug Administration (FDA) in the third quarter of 2021 to seek agreement on the design of a potential Phase 2 pivotal study and the overall clinical development plan to qualify TNX-102 SL as an indicated treatment for Long COVID. Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID, or PASC. These individuals experience a constellation of symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 virus from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as “brain fog”, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.2 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Seth Lederman, M.D., President and Chief Executive Officer of Tonix, stated, “We are excited to begin development of TNX-102 SL for the treatment of Long COVID because the program leverages what we have learned about the pharmacodynamic activity of TNX-102 SL from more than one thousand participants who have been or are enrolled in our fibromyalgia trials to date. Long COVID has been compared to fibromyalgia because of the common ...