Cannabinoid Agent Gets Orphan Drug Status for Complex Regional Pain Syndrome

The Food and Drug Administration (FDA) has granted Orphan Drug designation to BRC-002 for the treatment of complex regional pain syndrome (CRPS).

CRPS is a chronic condition that results in severe pain usually following an injury such as a fracture or surgery and can lead to comorbidities such as depression, anxiety, and sleep disorders. BRC-002 is an oral botanically-derived cannabinoid agent containing cannabidiolic acid, tetrahydrocannabinolic acid (<0.3%), and other minor cannabinoids. 

The investigational treatment is currently being studied in a randomized, placebo-controlled phase 1 trial (ClinicalTrials.gov Identifier: NCT06393101) evaluating the potential effects and mechanism of BRC-002 in adults with CRPS. The study enrolled patients 21 to 75 years of age with ongoing CRPS for at least 3 months who were not currently using any type of cannabis. The primary endpoint is the change from baseline in pain intensity and unpleasantness ratings using an 11-point visual analog scale in response to heat and ongoing CRPS pain. 

“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.

According to Biopharmaceutical Research Company, a phase 2 trial will begin enrollment by the end of 2025.

The FDA’s Orphan Drug designation is granted to medicines intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals.

This article originally appeared on MPR