News Alert: FSD Pharma – FDA Approval to Submit I.N.D. Application for Compound to Treat Covid-19 Patients
The FDA approved FSD Pharma to submit an Investigational New Drug (I.N.D.) application
FSD Pharma is a specialty biotech pharmaceutical company. FSD Pharma BioSciences, Inc., is a wholly-owned subsidiary. Moreover, it is a specialty biotech pharmaceutical R&D company focused on developing, over time, multiple applications of its lead compound FSD201, ultramicronized palmitoylethanolamide (PEA), by down-regulating the cytokines to effectuate an anti-inflammatory response.
In addition, upon a Phase 1 first-in-human safety study, the compound was deemed safe with no serious adverse side effects. Further, the US Food and Drug Administration recently gave the Company permission to submit an Investigational New Drug application for the use of FSD201 to treat COVID-19.
Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. Therefore, the Company is focused on developing FSD201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.
FSD’s mission is to focus on the development of FDA approved synthetic compounds that address unmet medical needs.
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