FDA Grants Orphan Drug Status to BRC-002 for Complex Regional Pain Syndrome

Biopharmaceutical Research Company (BRC), a specialty pharmaceutical firm focused on developing cannabinoid-based therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BRC-002. This designation is specifically for the treatment of Complex Regional Pain Syndrome (CRPS), which is currently being studied in an investigator-initiated Phase 1 clinical trial.

CRPS is a chronic pain condition that often arises following an injury such as a fracture or surgery. It is characterized not only by severe pain but also by co-morbidities including depression, anxiety, and sleep disorders. BRC-002 is a novel, botanically derived oral cannabinoid therapeutic candidate designed to address both the pain and the associated co-morbidities of CRPS. BRC's cannabinoid treatments include major and minor cannabinoids in specific, proprietary ratios.

George Hodgin, CEO and founder of BRC, emphasized the significance of the Orphan Drug Designation for BRC-002, noting that it highlights the urgent need to find safe and effective treatments for CRPS patients. He expressed confidence that this designation represents a critical step forward in their mission to offer a comprehensive solution that not only addresses pain but also aims to enhance the overall quality of life for these patients. Hodgin also mentioned that BRC looks forward to advancing this investigational treatment and sharing future updates.

Currently, there is no approved treatment for CRPS in the United States, underscoring the dire need for new therapeutic options for this underserved condition. BRC plans to begin enrollment for a Phase 2 trial by the end of 2025 and is actively seeking guidance from the FDA on the development plan.

The FDA's Orphan Drug Designation is granted to drugs intended to treat, prevent, or diagnose rare diseases or conditions that affect fewer than 200,000 people in the United States at the time of the designation. This designation offers various incentives, including tax credits for qualified clinical trials, exemptions from user fees, and the potential for seven years of market exclusivity following approval.

BRC, based in Monterey, California, is dedicated to developing proprietary cannabinoid therapeutics aimed at addressing high unmet medical needs. Their therapeutic products are polymodal, containing both major and minor cannabinoids in defined ratios. The company has developed a range of treatments targeting pain, neurological, and inflammatory conditions. BRC is registered with the Drug Enforcement Administration and continues to innovate in the field of cannabinoid therapeutics.

Biopharmaceutical Research Company remains committed to addressing significant medical needs through its pipeline of cannabinoid-based treatments. Their ongoing research and development efforts are focused on providing new solutions for conditions like CRPS, which currently have limited treatment options. As BRC moves forward with its clinical trials and seeks further input from the FDA, the hope is to bring much-needed relief to patients suffering from this debilitating condition.