High CBD Hemp Extract BRC-002 Receives Orphan Drug Designation from the US FDA for Complex Regional Pain Syndrome

Recently, Biopharmaceutical Research Corporation (BRC), a specialty pharmaceutical company developing proprietary cannabinoid therapies, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to high-CBD hemp extract [BRC-002] for the treatment of complex regional pain syndrome (CRPS). CRPS is a debilitating, chronic pain disorder often triggered by an injury such as a fracture or surgery. In addition to the severe pain, patients can suffer from complications such as depression, anxiety, and sleep disorders. For those who suffer from CRPS, the limited treatment options have led the condition to be referred to as "suicidal pain."

Currently, there are no FDA-approved treatments for CRPS in the United States, highlighting the urgent need for new therapeutic approaches. BRC-002 is a novel, plant-derived, oral cannabinoid therapeutic product candidate designed to treat both the pain and the associated complications of CRPS. BRC's cannabinoid therapeutics contain CBD (cannabidiol) and other minor cannabinoids in defined and patented ratios, making them highly effective for a variety of conditions.

On October 3, 2024, the first dose in the Phase 1 clinical trial of BRC-002 for Complex Regional Pain Syndrome (CRPS) was administered. The investigational treatment is being studied in a randomized, placebo-controlled Phase 1 trial (ClinicalTrials.gov Identifier: NCT06393101) to evaluate the potential effects and mechanisms of BRC-002 in adult patients with CRPS. The study enrolled patients aged 21 to 75 years who had persistent CRPS for at least 3 months and were not currently using any type of cannabis product. The primary endpoint of the trial is to measure responses to heat and persistent CRPS pain using an 11-point visual analog scale, evaluating changes from baseline in pain intensity and discomfort scores.

"The orphan drug designation for BRC-002 further demonstrates the need to find safe and effective treatment options for patients with CRPS," said George Hodgin, CEO and founder of BRC. "This designation represents our continued efforts to provide solutions for these patients and improve overall quality of life. This is another milestone, and Phase II trials will begin recruiting patients in late 2025.”

In the realm of medical cannabis packaging, BRC’s products and clinical trials are often accompanied by highly secure packaging, such as Child Resistant 1g 3.5g 7g 14g Gram Matte Black Soft Touch Mylar Bags for clinical samples. These Child Resistant Mylar Bags ensure safe storage of cannabinoid therapeutics, especially those intended for long-term use. The Mylar Bags Ziplock feature provides a secure, resealable option for maintaining product freshness. Given their opaque and extremely tear-resistant nature, Mylar Pouches offer both protection and durability for the highly sensitive contents of BRC's products.

BRC also holds six DEA registrations, which cover the full range of cannabinoid raw materials and finished products, including those stored in Mylar Bags. As the clinical trial advances, ensuring that BRC-002 remains properly protected and secure is paramount. In addition to child-proof packaging, Stand Up Pouches are often used for larger quantities, providing an effective smell-proof solution that keeps cannabis-derived products secure from tampering.

For those packaging or storing cannabinoids for therapeutic use, Mylar Bags are known for being hygienic, free of toxins, and suitable for freezing. Their sealability ensures that each dose is tightly closed, offering maximum protection. These features make Mylar Bags Ziplock an essential part of BRC’s packaging strategy, keeping products safe and fresh throughout the trial process.

Meanwhile, BRC is also developing BRC-001, a CBD formula drug targeting joint pain in breast cancer patients undergoing aromatase inhibitor therapy. As early as September 12, 2024, City of Hope and BRC announced that the first patient received BRC-001 for experimental supportive care therapies. Researchers are evaluating whether this cannabinoid therapeutic candidate can address joint pain, a common side effect of aromatase inhibitors.

Approximately half of patients taking aromatase inhibitors experience joint pain, with many reporting severe symptoms. This has led to discontinuation of cancer treatment. As there are no approved treatments for aromatase-induced arthralgia (AIIA), BRC-001 represents a promising alternative for managing pain. The clinical trial, titled "A randomized, controlled, double-blind trial of a standardized extract high in cannabidiol (CBD) for the treatment of aromatase inhibitor-induced joint pain," was conducted at City of Hope's Los Angeles Cancer Center. This study aims to evaluate the safety, tolerability, and efficacy of BRC-001 for the oral treatment of AIIA symptoms.

"Cannabis-derived medicines hold promise in relieving cancer symptoms and treating cancer," said Yuman Fong, MD, Sangiacomo Chair in Surgical Oncology at City of Hope. "They are a potential alternative to opioids for pain relief and benzodiazepines. We are excited to see the potential of these drugs as a potential alternative for relieving anxiety and insomnia. We look forward to working with BRC on trials to help cancer patients."