Discovering Medicines with Insight, Developing Medicines with Compassion
Dr. Kimless noticed that many of her Pennsylvania patients were using cannabidiol medicine to reduce pain. Deb and Steve met several years ago at a Heidelberg Germany medical conference and decided to combine their medical, drug formulation and business experience. They achieved the ECS / SL / WS effect and created the first CBD endocannabinoid system / sublingual / water soluble tablets.
They began running a series of patient-centric decentralized clinical trials and quickly learned the tremendous pain relief power these tablets provide people. Not content to keep this information to themselves, they published their breakthrough results, first on the National Institutes of Health website clinicaltrials.gov and then in international referred medical journals, J of Diabetic Neuropathy and J of Pain Medicine.
Inspired by Science, Compelled by Data
Pure Green Pharmaceuticals is committed to publishing our clinical data for patients and physicians to review. The first 3 clinical trials added significantly to worldwide medical knowledge of the endocannabinoid system.
The first clinical test, in only 16 patients, with a single dose of 5 mg CBD SL/WS tablet showed that people with everyday aches and strains could feel significant pain relief in less than 20 minutes, lasting 4 hours and more.
Figure 1 (Above):Individual NPRS scores of each subject at each measured time point, starting with pre-treatment scores (T-0), and then 20 minutes, 40 minutes, 60 minutes and 120 minutes after taking a single 5 mg CBD tablet. Results show each subject experienced a reduction in pain in 20 minutes after taking one 5 mg CBD tablet and a significant reduction in pain in 120 minutes.
Figure 2 (Above): Average pain scale scores of 16 subjects at each measured time point starting with time zero and then 20 minutes, 40 minutes, 60 minutes and 120 minutes after taking a single 5 mg CBD tablet. Results show a significant improvement in pain from moderate (5.13) to tolerable (2.0) in 20 minutes and a drop in the average pain score to very mild (0.25) in 120 minutes after a single 5 mg CBD tablet.
That clinical demonstration set the foundation for a 28 day, 3 times daily dose of 20 mg CBD SL/WS in 31 patients suffering from severe chronic diabetic neuropathic pain [more than 5 on a pain scale of 1-10]. All 31 patients received statistically and clinically significant pain reduction. Perhaps even more important, the patients who were on current pain medication were allowed to stay on their chosen medication, but still received powerfully significant additional pain relief from our medication.
The medical community was hugely excited by this breakthrough diabetic pain relief medication because no patients suffered adverse events or side effects, but got very effective pain relief. We repeated that clinical trial but this time made it ‘tougher’ on our medication by having a placebo patient group because pain relief studies have a very large placebo effect. Once again, all patients on the 3 times daily dosage of 20 mg CBD SL/WS tablets showed very strong statistical and clinical efficacy during the 28 day trial period.
Figure 1: Mean NPRS scores per group across weekly time points after taking one CBD tablet three times a day for 28 days.
Figure 2: Highest NPRS scores at any given time per group across weekly time points after taking one CBD tablet three times a day for 28 days.
The medical community has signaled this data is compelling and we will continue to show results in Diabetes and soon we will have osteoarthritis pain relief clinical data.