FSD Pharma has successfully completed a Phase 1 first-in-human safety and tolerability study for FSD201 that found the compound to be safe with no serious adverse side effects. This study also validated considerable scientific literature published in Europe that claims safety and tolerability of micro-PEA. Ultra-micronized PEA has been dispensed in Italy and Spain as a prescription anti-inflammatory medical food supplement since 2004, with no serious adverse side effects reported.
On June 1, 2020, the Company received permission from the U.S. Food and Drug Administration (FDA) to submit an Investigational New Drug (“IND”) application for the use of FSD201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus.
Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. 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.
FV Pharma, a wholly-owned subsidiary, is a licensed producer under Canada’s Cannabis Act and Regulations, having received its cultivation license on October 13, 2017 and its full Sale for Medical Purposes license on June 21, 2019. The Company is licensed to cultivate cannabis in approximately 25,000 square feet of its facility in Cobourg, Ontario.