TORONTO--(BUSINESS WIRE)--FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRE: 0K9A) (“FSD Pharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, today announces that it received “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 corresponding study protocol is titled “A Randomized, Double-Blind Placebo Controlled Parallel Group Study of Safety and Efficacy of FSD201 in Patients with Chronic Widespread Musculoskeletal Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome (Disorder)”.
TORONTO--(BUSINESS WIRE)--FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRE: 0K9A) (“FSD Pharma” or the “Company”), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today that is wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), filed a provisional patent application on novel formulations of palmitoylethanolamide (PEA). The new patent application is based on the results of completed preclinical animal toxicology studies and phase 1 clinical trial using FSD201 (ultramicronized PEA), sponsored by FSD Pharma. Patent applications are important tools to protect intellectual property of the company for commercialization and value proposition for the shareholders.
Advanced Orthomolecular Research (AOR), maker of science-backed dietary supplementation, is pleased to announce the launch of P.E.A. Endocannabinoid Support, a novel way to combat minor chronic discomfort and support a healthy inflammatory response. While consumer interest in the benefits of CBD has grown, there are still many who hesitate to integrate the ingredient into their wellness routine due to its stigma. AOR's P.E.A. supplement, available in the U.S., offers consumers a safe, effective and efficient way to support their endocannabinoid system without having to experiment with CBD.