BRC-002 receives Orphan Drug Designation from FDA for Complex Regional Pain Syndrome
• Safety and efficacy are currently being assessed in investigator-initiated clinical trial.
• BRC is planning to commence enrollment for a Phase 2 trial by the end of 2025.
MONTEREY, Calif. (December 3, 2024) — Biopharmaceutical Research Company (BRC), a specialty pharmaceutical company developing proprietary cannabinoid therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the treatment of Complex Regional Pain Syndrome (CRPS) to BRC-002, which is being investigated in an investigator-initiated clinical Phase 1 trial. Visit www.clinicaltrials.gov for more information.
CRPS is a debilitating chronic pain condition that is often triggered by an injury, such as a fracture or surgery. In addition to severe pain, patients can suffer from co-morbidities such as depression, anxiety, and sleep disorders. BRC-002 is a novel, botanically derived oral cannabinoid therapeutic product candidate aiming to address pain and co-morbidities of CRPS. BRC’s cannabinoid therapeutics contain major and minor cannabinoids at defined and proprietary ratios.
“The Orphan Drug Designation for BRC-002 reinforces the urgency to identify safe and effective treatment options for patients afflicted with CRPS” said George Hodgin, CEO and founder of BRC. “The designation represents another milestone in our efforts to provide a holistic solution for these patients by addressing pain and improving overall quality of life. We look forward to progressing this investigational treatment and sharing updates in the near future.”
Currently, there is no approved treatment for CRPS in the United States, highlighting the critical need for new therapeutic approaches for this underserved disease. BRC is planning to commence enrollment for a Phase 2 trial by the end of 2025 and is currently seeking input from the FDA on the development plan.
The FDA grants Orphan Drug Designation to a drug intended to treat, prevent, or diagnose a rare disease or condition that affects fewer than 200,000 people in the US at the time of designation. The designation provides incentives, such as tax credits for qualified clinical trials, user fee exemptions, and the potential of seven years of market exclusivity after approval.
