Medlab Clinical Limited (ASX: MDC) has been granted an important licence by the Victorian State Government for its cannabis-based medicines.
The licence enables Medlab Clinical to sell or supply Schedule 8 or 9 drugs (in this case, specifically cannabis and derivative products). The company will sell its NanaBis and NanaBidial products under this licence.
NanaBis (NanoCelle CBD/THC) is designed to act as an adjunct to opioid analgesia for managing intractable pain in patients diagnosed with advanced cancer. NanaBidial (NanoCelle CBD) is a CBD-only product targeting treatment of anxiety and potentially insomnia.
“NanoCelle” refers to the Medlab developed nano-particle medicine spray delivery system, designed for more effective dosing via buccal (cheek)/nasal administration.
“We are seeking to make our medicines distinctive, giving medical practitioners, Government and industry stakeholders such as the Australian Medical Association (AMA) confidence in prescribing our products,” said Medlab CEO Sean Hall..
The granting of the licence, which allows Medlab to sell in other states, means the company is on target for NanaBis being available late next month via the Therapeutic Goods Administration (TGA) Special Access Scheme. NanaBidial is still some way off from being available.
Access to NanaBis has been made possible due to fairly recent changes to the TGA’s Special Access Scheme, making Medlab’s cannabis medicines available based on specific needs.
Medlab says NanaBis is currently being produced at a Pharmaceuticals Packaging Professionals facility in Melbourne, Victoria.
In June last year, Medlab Clinical received the green light to commence human trials of NanaBis and NanaBidial. A clinical trial of NanaBis will soon take place at Royal North Shore Hospital in Sydney with seriously ill onconcology patients, under the supervision of Professor Stephen Clarke OAM.
Another trial, this one a safety, tolerability and pharmacokinetic exploratory pilot study of NanaBidial, will also occur in the near future.
Mr. Hall is very pleased with Medlab’s progress to date, especially given the complexities of Australia’s cannabis industry.
To date, Medlab and partner Aphria have completed two medical cannabis shipments into Australia, which have provided materials for product development