FSD Pharma (NASDAQ: HUGE | CSE: HUGE | FRA: 0K9A) is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide. The company today announced that recruiting is underway for its phase 2 trial of FSD201 for the treatment of chronic pain associated with idiopathic MCAS (“MCAD”) at two clinical sites in the USA, with a Canadian site to be ready to recruit soon.

“FSD201 is a unique proprietary formulation of palmitoyl ethanolamide, and already received the new molecular entity (‘NME’) designation for a potential 505(b)(1) application to the U.S. FDA. This is attractive because of the potential exclusive regulatory access to the U.S. market. Our clinical team put in a lot of thought into exploring unmet needs in inflammatory disorders and associated conditions. We are excited to evaluate the efficacy and safety of FSD201 in the treatment of chronic widespread musculoskeletal nociplastic pain associated with idiopathic MCAS, a disease that has challenged caregivers and researchers since the first case was diagnosed in 2007, and potentially millions of patients have a significantly reduced quality of life,”

Head of FSD Pharma’s FSD Biosciences and CEO of Lucid Psycheceuticals Dr. Lakshmi P. Kotra

“Owing to the complexity of the disease, the therapeutic market is grossly underserved, presenting us with an opportunity as a pioneer in the space to provide a novel therapeutic option to scores of MCAS patients desperately in need of safe alternatives to the current standard of care. We feel we are in a position with only a handful of companies conducting clinical trials for this indication.”

About FSD Pharma Inc.

FSD Pharma is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences Inc., a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound, FSD201, an ultra-micronized PEA formulation, for the treatment of inflammatory diseases. Lucid Psycheceuticals Inc., a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-Psych and Lucid-MS. Lucid-Psych is a molecular compound identified for the potential treatment of mental health disorders, and expanding this category, the company is investigating other products addressing acute medical needs due to the abuse of drugs such as alcohol. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders