Australian medical cannabis company Medlab Clinical Ltd (ASX:MDC) announced on Tuesday it had received an export permit from the Australian Office of Drug Control (ODC) for a CBD and THC based medicine.
The export permit is in relation to NanaDol, which is a spray containing 9.62 mg/mL of cannabidiol (CBD) and 9.62 mg/mL of tetrahydrocannabinol (THC). While known as Nanabis here, it will be exported under the NanaDol name for the UK market.
“NanaDol will be exported to the UK where the Company’s partner, WEP Clinical, will supply UK patients as appropriate,” said Medlab. “Several hundred units of NanaDol are expected to ship as soon as secure freight has been arranged.”
The announcement follows news in late January that NanaDol had been issued an import certification by the UK Home Office. NanaDol was approved in November last year by the UK Medicines and Healthcare Product Regulatory Agency (MHRA) for use in the UK Named Patient Program, and compassionate areas as an unapproved medicine.
NanaBis is being developed for cancer bone pain. A published clinical trial carried out by Professor Stephen Clarke at Royal North Shore Hospital in Sydney indicated these patients received a clinically significant (40%) reduction in pain using NanaBis.
“It’s great to be able to expand the successes we have had with NanaBis (named NanaDol for export purposes) to the UK people,” Medlab CEO Dr Sean Hall CEO last month. “As we recently announced, those data points across 1,100 Australian patients were very encouraging. We are looking forward to replicating those success stories.”
NanaBis/Nanadol is encapsulated in Medlab’s patented delivery platform, NanoCelle, which we’ve mentioned a few times in the past here on HempGazette. This involves sub-micron spray applied to the inside of the cheek. Medlab says the extremely small particle size improves bioavailability, meaning more effective dosing and therapeutic levels able to be achieved with a lower dose.
A University of South Australia study published last year found NanaBis delivered with NanoCelle had two times more bioavailability than an ARTG (Australian Register of Therapeutic Goods) approved oral cannabis (CBD and THC) medicine. Medlab has previously asserted five times bioavailability compared to other ingested (swallowed) medicines.