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Tonix Pharma Plans To Develop TNX-102 SL For Treatment Of Long COVID Syndrome

Tonix Pharmaceuticals Holding Corp. (TNXP) said that it plans to develop TNX-102 SL or cyclobenzaprine HCl sublingual tablets as a potential treatment for Long COVID Syndrome which is now known officially as Post-Acute Sequelae of COVID-19 or PASC.

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.

Tonix noted that it plans to meet with the U.S. Food and Drug Administration 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.

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. Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection.

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