Ann: Final Sofdra Labelling Discussions with FDA, page-133

CBD is becoming well known for its strong anti-inflammatory (including neuroinflammation) effects. There are no side effects and no addiction risks with CBD. These effects are driving enormous growth for over the counter products and Botanix is seeking to capitalise on this popularity with more potent prescription products.Topical administration of a drug onto the skin has distinct advantages over oral and injectable drugs in dermatology. Topical products tend to cause fewer side effects and are more successful at delivering drug to the targeted disease area as compared to orally administered CBD where around 6% of the drug reaches the bloodstream. Additionally, Botanix assert that 5% Permetrex CBD formulation delivers more drug to the target area than regular 20% and 10% CBD topical formulations using traditional skin delivery technologies. Sofdra's FDA approval will be the first of many for PermatrexTM -Skin delivery technology, which is an evaporative gel formulation that contains synthetic cannabidiol (CBD) as an ingredient.
Botanix's emollient use of synthetic CBD will be only the second FDA approved cannabinoid product after Epidiolex.