Over 100 Australian doctors and 200 patients have been enrolled in the observational study.
() is progressing its Ethics Observational Study for NanaBis, a highly purified proprietary blend of cannabis molecules cannabidiol (CBD) and tetrahydrocannabinol (THC).
The pain management medicine is delivered into the body using Medlab’s patented sub-micron delivery platform NanoCelle.
Clinical trials pathway to drug registration
The Ethics Observational Study is part of Medlab’s commitment to clinical trials pathway to drug registration for NanaBis that includes the current study close to completion at The Royal North Shore Hospital in Sydney.
The study is assessing real-world use of NanaBis, provide further evidence for safety and tolerability and review the impact NanaBis has on current prescriptive medicines used in pain settings, thus bolstering Medlab’s goal of drug registration.
Medlab CEO Dr Sean Hall said: “This Observational Study is critical in understanding real world use, dosing in relation to other prescribed medications and any potential effects to the patient.
“The study is a unique vehicle protecting Medlab, the doctor and patient under an Ethics agreement.
“Moving forward, we are very optimistic as to the NanaBis™ benefit for the assumed patient cohort.”
Initial tests successful
Because of the sensitivity of the patient data, for the last 12 weeks Medlab has soft-launched the study to test and harden the process around data collection, transport and management.
These tests have all successfully concluded.
Data to date:
Over 100 Australian doctors so far have agreed and are participating in the study Over 200 Australian Patients, representing 10% of the anticipated cohort have been invited to participate and have been successfully recruited into the study, of which 66% are female with an average age of 56 years. Dosage guidelines averaged to be 2 sprays per day which is well below the dosage models used in the RNSH NanaBis trial, with all patients reporting pain reductions. 50% of the recruited patients were diagnosed with neuropathic pain.National rollout in January 2020
Medlab director of medical research Prof Luis Vitetta said: “An observational study on the safety, tolerability and efficacy of Medlab’s cannabisbased medicine NanaBis is providing extremely noteworthy and very encouraging results for the effective management of pain, as well as the future development of the company’s cannabis-based medicines.”
Medlab is expected to formally launch the Observational Study, nationally in January.
