Clinical research on human drugs that contain cannabis can be conducted legally as long as the amount of the substance in the investigational product is within limits set by a new FDA draft guidance.
Cannabis-derived products can be used in human trials as long as the products contain less than 0.3 percent delta-9 tetrahydrocannabinol (THC). The guidance suggests that investigators calculate the level of delta-9 THC in their proposed product early in the development process to gain insight into potential control status of the product.
The FDA also recommends that sponsors provide quantitative data indicating the amount of THC in their products and detailed descriptions of testing methods used to evaluate THC levels.
In addition, the guidance states that cannabis is held to the same regulatory standards as any other botanical product and suggests ensuring batch-to-batch consistency of products via a chemical fingerprint.
Currently, there is only one FDA-approved product that uses a cannabis extract. GW Pharmaceuticals’ Epidiolex was approved in 2018 for seizures related to Lennox-Gastaut syndrome and Dravet syndrome.
Read the full guidance here: https://bit.ly/2WTf8U1.