FSD Pharma, a biopharmaceutical firm listed on NASDAQ and CSE, has submitted a Clinical Trial Application (CTA) for a Phase-1b study, the METAL-1 TRIAL, to evaluate the safety and efficacy of its dietary supplement, unbuzzd™, in healthy volunteers experiencing induced alcohol intoxication. The application is under review by a human ethics review committee (HREC) in Australia, which is a prerequisite for the trial's commencement. FSD Pharma anticipates starting volunteer recruitment in April, pending HREC approval.
Unbuzzd™, a dietary supplement in development for the U.S. market, is an enriched oral liquid formula containing natural ingredients, vitamins, and other supplements. It is designed to enhance cognitive function, replenish cofactors necessary for alcohol metabolism, and has demonstrated the ability to speed up the body's alcohol metabolism rate.
Dr. Andrzej Chruscinski, Vice-President of Scientific and Clinical Affairs at FSD Pharma, highlighted the significance of the clinical trial, which is the result of extensive work by the company's team and advisors. John Duffy, CEO of Celly Nutrition, the company that will market unbuzzd™, emphasized the product's potential to accelerate alcohol metabolism, restore mental alertness, and improve cognition post-consumption, based on scientific research. Duffy, who has over 22 years of experience at Coca-Cola, including as Vice President for national sales, is enthusiastic about bringing this innovation to U.S. consumers.
Gerry David, retired CEO of Celsius Energy Drink, also expressed optimism about unbuzzd™'s positive impact on many lives and his eagerness to contribute to its mainstream success.
FSD Pharma is focused on developing a portfolio of innovative assets and solutions for treating neurodegenerative, metabolic disorders, and alcohol misuse disorders. The company, through its subsidiary Lucid Psycheceuticals Inc., is developing Lucid-MS, a patented compound that has shown promise in preventing and reversing myelin degradation, a key mechanism in multiple sclerosis. FSD Pharma has also licensed unbuzzd™ to Celly Nutrition Corp., granting them the rights to use the proprietary formulation for products aimed at the consumer recreational market, with FSD Pharma receiving royalties from sales.
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