Medlab Clinical Ltd. announced interim readouts of its Medcare Observational Study, Human Research Ethic Committee (HREC) number 005E_2019, titled "An observational study investigating and auditing the safety, tolerability and further efficacy characteristics of a pharmaceutical-grade cannabis medicine
(NanaBisTM) that is currently or will be prescribed to eligible patients for the management of cancer- related and non-cancer related pain in general and speciality medical practices." By way of summary, 244 doctors attended 1,172 Australian patients and collected data monthly from the start of the study (baseline) to a maximum of 12 months, as appropriate to the patient and their disease condition. Patients and Doctors were consented into a long-term real-world program with the following outcomes: Primary Outcomes: · The collection of Adverse Events/Serious Adverse Event that may occur · Patient withdrawal and reason · Indication and dosage capture and subsequent changes Secondary Outcomes: · Efficacy in treating pain and quality of life (BPI-SF and SF-12) · Concomitant medications and changes thereof · Rationale for dosage/treatment changes. The average duration of NanaBisTM treatment under this study was 5.4 months (95% confidence interval [CI], 5.1-5.6 months), with at least 77 patients continuing to receive NanaBisTM post study completion. The female to male ratio was 3:2, with the 36-55 years old and 56-70 years old age ranges comprising 32.5% and 26.0% of all patients, respectively, and representing the two major age segments in the study. Of the study group: · 98.5% had chronic pain, 1.5% had acute pain · 85% had non-cancer pain and 15% had cancer pain · 55% had a neuropathic component Pain Severity1 reduction profiles (Brief Pain Inventory) across the study group showed an average pain reduction of 23% (95% CI, 16-30%; p<0.0001) after 6-months of NanaBisTM treatment, and a 27% (95% CI, 17-37%; p<0.0001) average pain reduction at the 12-month time point. Patients reported a 55% (95% CI, 36-74%; p<0.00001) improvement in Pain Relief2 after 6 months of NanaBisTM treatment, which was a significantly larger improvement than the 23% reduction in Pain Severity (p = 0.001). This could be due to patients increasing activity levels and reducing opioid use because of NanaBisTM treatment3. The cancer-pain patient subgroup showed an average Pain Severity reduction of 25% (95% CI, 9-41%), 33% (95% CI, 9-57%), 24% (95% CI, 2-46%) and 31% (95% CI, 2-58%) after 1, 3, 6 and 9 months of NanaBisTM treatment and a 49% (95% CI, 20-78%) average Pain Severity reduction at the 12-month timepoint.