Chronic pain treatment developer Medlab Clinical has received good results from its 12-month observation study of NanaBis, a cannabinoid treatment for cancer-induced bone pain which will help it progress towards a global Phase III study slated to commence in 2021.
NanaBis is a highly purified blend of THC:CBD that has been optimised for use at sub-micron (nano-sized) doses using Medlab’s proprietary drug delivery platform, NanoCelle. It is being developed as non-opioid alternative for the treatment of cancer-induced bone pain.
Managing director Dr Sean Hall said: “Not only does the study help us to build a base of prescribers and patients for NanaBis who can access this drug under the Special Access Scheme, it supports our ultimate goal of achieving US regulatory approval for NanaBis as a treatment for cancer- induced bone pain.
“There is an urgent need to provide a viable alternative to opioids for the treatment of cancer-related pain – and ultimately chronic pain in general. The strong body of evidence we are collecting, the scientific quality of our product and the progress we are making towards a global Phase III study differentiates us from other medicinal cannabis plays,” said Dr Hall.
Consistent with the previous results from the earlier Phase I/II study undertaken at Sydney’s Royal North Shore Hospital, the fourth monitoring report on the 12-month observational study of NanaBis has demonstrated a 55% reduction in pain scores. The study also observed significant improvements in quality of life outcomes such as ‘general activities’, ‘sleep’ and ‘mood’.
The company has prepared the first of its Investigational New Drug (IND) submissions to the US Food and Drug Administration (FDA) for approval of NanaBis use in connection with the study. This submission has been prepared taking into account feedback from ongoing dialogue with the FDA.
“Acceptance of the IND(s) will be important milestones, enabling us to move forward with the study but also providing validation from the regulator of the merit of our safety, quality and clinical data collected to date,” said Dr Hall.