FDA has approved an investigational new drug application for a clinical trial to evaluate CBD as an adjunctive method to treat opioid use disorder.
According to the FDA, during a new drug's early pre-clinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans and if the compound exhibits pharmacological activity that justifies commercial development. The company can collect the data and information needed to establish the impact on humans when used in limited, early-stage clinical studies only when a product is evaluated as an ideal candidate for further development.
However, the debate over CBD as a treatment to ease the opioid crisis is still divisive. Although some think cannabis could offer an alternative to opioids for "The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims," said FDA Principal Deputy Commissioner Amy Abernethy in a press release.
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