FSD Pharma (NASDAQ: HUGE) (CSE: HUGE) (FSE: 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 its receipt of a “Study May Proceed” letter for the Investigational New Drug (“IND”) application from the U.S. Food and Drug Administration (“FDA”) and “Notice of Authorization” from Health Canada for its phase 2 clinical trial of FSD201. The trial will study the safety and efficacy of FSD201 in patients with chronic widespread musculoskeletal nociplastic pain associated with idiopathic mast cell activation syndrome. “We are delighted to receive authorization to proceed with our planned efficacy clinical trial of FSD201 from both FDA and Health Canada. We are working with our clinical sites in the U.S. and Canada to initiate the study and intend to release more details on the study very soon,” said Dr. Lakshmi Kotra, CEO of FSD Pharma subsidiary Lucid Psycheceuticals. “Our regulatory and clinical teams led by Dr. Andrzej Chruscinski, vice-president for clinical and scientific affairs, worked tirelessly with our expert advisors developing the protocols, and we are looking forward to the next stage of clinical development of FSD201. We believe FSD201 is a compelling drug candidate, and we are actively exploring opportunities for development partners and other synergistic collaborations that will maximize shareholder returns.”
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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, 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. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders. For more information, visit the company’s website at www.FSDPharma.com.
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