Pure Green Pharmaceuticals Reports Unexpected Results of a Randomized, Placebo Controlled Clinical Trial with Sublingual CBD in Patients with Painful Diabetic Peripheral Neuropathy
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%.
WEST BLOOMFIELD, Mich., May 13, 2021 /PRNewswire/ -- Pure Green Pharmaceuticals, Inc. today announced that a confirmatory double blind, placebo controlled clinical trial in diabetic patients with moderate to severe neuropathic pain showed statistically and clinically significant improvements in both average pain and highest pain scores for patients treated with the company's proprietary water-soluble CBD sublingual tablets versus patients who received placebo. In addition, patients who received active treatment also experienced statistically significant improvement in quality of life and clinically significant improvements in sleep quality and anxiety.
The study enrolled 54 patients with painful diabetic peripheral neuropathy (pDPN) who were randomized to either the Company's proprietary 20mg water-soluble CBD sublingual tablets three times daily or placebo for 28 days. The group of patients who received active treatment experienced significantly reduced highest pain level versus the placebo group (p<0.001) and significantly reduced average pain level compared to the placebo group (p<0.001).
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."
Stephen Goldner, CEO 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."
Diabetic peripheral neuropathy (DPN) affects upwards of 50% of patients with diabetes. According to the CDC, 34.2 million people in the United States have diabetes and another 88 million have pre-diabetes. DPN is damage to peripheral nerves in the feet and hands due to chronic elevated blood sugar. The damage to the nerves results in debilitating pain that adversely impacts both quality of life and healthcare costs. According to the Journal of Diabetes Complications, the costs of pDPN were approximately $30,000 per patient per year in 2015, far outpacing healthcare resource utilization and costs from diabetes patients without pDPN.
Pure Green Pharmaceuticals is a clinical-stage prescription pharmaceutical company dedicated to the development of novel cannabinoid therapies for a number of chronic diseases and conditions where patient need for improved treatment is great. Company's patent pending method uses Cannabidiol (CBD) manufactured to pharmaceutical standards as water-soluble rapid disintegrating
sublingual tablets. This innovative treatment modality delivers the medication in minutes, with enhanced efficacy through increased bioavailability.
Contact: Jim Smith, Pure Green Pharmaceuticals (650) 454-0811; [email protected]
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