Sublingual Cannabidiol Tablet Shows Efficacy for Treating Diabetic Peripheral Neuropathy in Phase 2 Trial

Treatment with a proprietary form of cannabidiol (CBD) as water-soluble sublingual tablets (Pure Green Pharmaceuticals, West Bloomfield, MI) provided statistically significant pain relief compared with placebo. In a confirmatory phase 2 clinical trial, (NCT04679545) individuals with painful diabetic peripheral neuropathy (pDPN, n=54) were randomly assigned to receive the CBD formulation or placebo 3 times per day. Those treated with CBD had statistically and clinically significant improvements in average and highest pain scores compared with those treated with placebo (P<.001). Individuals treated with CBD also had statistically significant improvements in quality of life and in sleep quality and anxiety (P<.001).

Stephen Goldner, chief executive officer and long-time FDA expert, said: "A collaborative drug development meeting with FDA set us on this path and we look forward to returning to FDA to share this data. FDA is keen to relieve patient suffering in this very large patient population, especially since Covid-19 appears to have increased the number of diabetic patients." 

Chief medical officer and board-certified anesthesiologist, Dr. Debra Kimless said: "Achieving clinical and statistical pain relief for these patients in just a few weeks is very gratifying and frankly unexpected. Interestingly, the results of this placebo-controlled trial mirrored those of Pure Green Pharmaceuticals' open-label pDPN trial where both studies revealed a significant drop in pain scores by approximately 50%. Patient safety always comes first and was our primary marker. There were no adverse events in either clinical trial to patients on treatment medication."