A University of South Australia study of Medlab Clinical’s Nanabis formulation and delivery system has returned favourable bioavailability results.
NanaBis contains 1:1 ratios of CBD and THC in a sub-micron spray applied to the inside of the cheek using Medlab’s NanoCelle system. Medlab says the tiny size of the particles improves bioavailability, meaning more effective dosing and achieving therapeutic levels with a lower dose.
The improved bioavailability claim has been confirmed by a University of South Australia study states the company, which found NanaBis has two times more bioavailability than an ARTG (Australian Register of Therapeutic Goods) approved oral cannabis (CBD and THC) medicine. While the medicine compared to Nanabis isn’t named, it’s assumed to be Sativex (nabiximols).
Medlab Clinical (ASX:MDC) says prior work demonstrated a five times bioavailability compared to other ingested (swallowed) medicines.
NanaBis has undergone clinical trials in the past, with more to come. Another is to demonstrate the analgesic efficacy of NanaBis as a monotherapy in cancer participants. At this point the trial is scheduled to begin in November next year with around 360 participants.
The company has another Nanocelle related cannabinoid product, NanoCBD, which as the name suggests only contains cannabidiol. NanoCBD is based on a hemp oil extract. In Australia, NanoCBD and NanaBis are currently available under the Therapeutic Goods Administration’s Special Access Scheme.
In February last year, Medlab Clinical announced an agreement with Arrotex involving fast-tracking a clinical package for final lodgement of an application via the TGA for a Schedule 3 (S3) pharmaceutical. Schedule 3 is “pharmacist only”, meaning a prescription isn’t required. There hasn’t been much news on this since.
In April this year, Medlab said it was ready to export NanoCBD to the UK market under a compassionate access program after having been granted most of the necessary licences. At that point it was awaiting the final import license from the UK Government. This, the company said, would be closely followed by NanaBis. However, NanaBis will be renamed as NanaDol in the UK market due to naming conventions associated with exporting non-approved pharmaceutical agents from Australia.
