Cannabis relief from ONP

Published: 18-Sep-2002
Regulatory


UK company Oxford Natural Products (ONP) is developing a cannabis-based treatment for cancer patients. ONP-04, a pro-drug of D9-tetrahydrocannabinol hemisuccinate (THC), a main ingredient of cannabis, has successfully completed Phase I clinical trials and will soon be entering Phase II trials.

Delivered via a suppository, ONP-04 will be used to relieve pain, as well as treating the nausea and vomiting associated with chemotherapy.

ONP's Phase I trial, conducted with Inveresk Research, involved 30 healthy volunteers and was conducted in two parts: part 1 assessed tolerability and measured blood levels of the active drug, while part 2 compared the bioavailability of ONP-04 with the licensed THC product, Marinol.

The results from Phase I showed that, as opposed to the oral route, delivery of the THC-derivative by rectal administration avoided degradation in the liver and provided improved bioavailability, with a more sustained and more consistent drug delivery level.

The use of the suppository formulation will be advantageous in circumstances where nausea and vomiting may be present after cancer chemotherapy, or in the immediate post-operative period.

The main component of ONP-04, THC, is licensed to ONP by the University of Mississippi. The University holds patents for the formulation, medical use and process for THC and is the only licensed producer of cannabis in the US.

For progression of ONP-04 through Phase III, ONP intends to find a development partner who will take the product to market, at which point ONP will pay the university royalties on sales.

Commenting on the trials, chief executive officer, Christian Hoyer Millar said: 'Cannabis has long been known to be effective in pain management - by using this derivative in a suppository format we have achieved our aim of delivering the drug with minimal side effects, over a sustained period of time.'

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