BRC Celebrates Regulatory Milestone in Cannabinoid Therapeutics Development After FDA Meeting

BRC's Regulatory Milestone with FDA

On January 29, 2025, Biopharmaceutical Research Company (BRC), a pioneer in cannabinoid therapeutics, achieved an important milestone by successfully engaging with the U.S. Food and Drug Administration (FDA) during a Type C Chemistry, Manufacturing and Controls (CMC) meeting. This achievement marks a significant step forward in the clinical development of BRC's therapeutic candidates, which are designed to address complex medical conditions.

BRC is currently advancing the clinical trials of two promising therapeutics. One is aimed at Complex Regional Pain Syndrome (CRPS), while the other targets Aromatase Inhibitor Induced Arthralgia (AIIA). Both candidates are currently undergoing assessment in investigator-initiated clinical trials, with Phase 2 and Phase 3 trials projected to commence by mid-2026, contingent upon the clearance of the investigational new drug (IND) application.

The CMC procedures that BRC has put in place are crucial for ensuring that its products meet the rigorous standards set by regulatory authorities. George Hodgin, CEO and founder of BRC, emphasized the significance of these procedures, stating, "BRC has established and implemented CMC procedures for clinical use within a short time frame." This focus on regulatory compliance not only ensures patient safety but also streamlines the road to commercialization.

Lucas Zumstein, VP of Operations, shed light on the company’s rapid growth and achievements in a relatively short period. "Over less than two years, we committed ourselves to establishing our CMC procedures and having two of our candidates enter the clinic," he noted, pointing out that BRC has successfully set up a state-of-the-art manufacturing facility equipped with full cGMP (current Good Manufacturing Practice) capabilities for clinical use. This underscores the competency and resilience of the entire BRC team, who have worked diligently to meet these stringent requirements.

BRC's cannabinoid therapeutics contain a blend of major and minor cannabinoids in proprietary ratios, designed to offer a polymodal therapeutic approach. The CMC strategy focuses on the development of manufacturing protocols, stability evaluations, and comprehensive product testing, which are critical steps in the drug development process. Ensuring consistency across all stages of development is vital to achieving eventual marketing approval.

Looking ahead, BRC’s strategic engagement with the FDA not only facilitates the progress of its therapeutic candidates but also lays the groundwork for an expedited path to market approval. The FDA’s insights into BRC's manufacturing practices represent a pivotal step in advancing these essential medicines, which aim to fulfil critical unmet medical needs.

About Biopharmaceutical Research Company (BRC)

Biopharmaceutical Research Company (BRC) is dedicated to developing innovative cannabinoid therapeutics meant to address significant medical deficiencies. With a pipeline targeting pain and various neurological and inflammatory disorders, BRC is poised for growth in the biopharmaceutical landscape. The company maintains compliance with Drug Enforcement Administration regulations and is based in Monterey, California.

For more information about BRC and its ongoing projects, please visit BRC's official website.