BRC Therapeutics announced that the FDA has cleared its investigational new drug application for BRC‑002, allowing the company to proceed with a Phase I study in healthy volunteers to further evaluate safety. BRC‑002 is described as a first‑in‑class investigational product intended to address pain and other symptoms of complex regional pain syndrome (CRPS).
According to the company, BRC‑002 has received Orphan Drug Designation from the FDA for the treatment of CRPS. The product is characterized as a multimodal botanical drug composed of prescription‑grade cannabinoids formulated at defined proprietary ratios.
BRC Therapeutics notes that CRPS is a chronic pain condition with limited treatment options, and that the condition may last for a year on average and can persist for five years or longer in many patients. In addition to pain, people with CRPS may experience depression, anxiety, and sleep disorders. The company states that there are currently no approved treatments for CRPS in the United States.
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