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This investigational drug is an oral tablet formulation containing plant-derived cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), developed by the Yale University School of Medicine in collaboration with CTPharma (now part of Verano Holdings). The product is designed to treat chronic pain and stress by targeting the endocannabinoid system and voltage-gated sodium channels, specifically the Nav1.8 subunit (SCN10A) in sensory neurons. This study is historically significant as one of the first FDA-approved clinical trials to utilize U.S.-grown cannabis sourced from a state-licensed producer rather than the National Institute on Drug Abuse (NIDA). The Phase 1 trial evaluates the safety, pharmacokinetics, and efficacy of various CBD and THC ratios in adults with chronic pain, including those whose pain is not fully managed by opioid medications.
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