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FSD Pharma Wins FDA OK to File Investigational New Drug Application for Potential COVID-19 Treatment

5:14AM ET 6/03/2020 MT Newswires
FSD Pharma (HUGE) said Wednesday it has received approval from the US Food and Drug Administration to submit an investigational new drug application for FSD-201, or ultramicronized palmitoylethanolamide, its treatment candidate for COVID-19.

The permission to file an IND allows the company to design a proof-of-concept study in COVID-19 patients evaluating clinical doses of FSD-20. The primary endpoint of the study is to determine if adding FSD-201 to the standard of care will significantly improve the time to symptom relief.

Key secondary objectives include additional benefit in terms of safety, and length of time in the improvement of oxygen saturation, among others.

The company said the therapeutic effects of ultramicronized palmitoylethanolamide are supported by more than 600 scientific papers.

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