GW Pharmaceuticals, the company licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop prescription cannabis-based medicines, has commenced its clinical programme. A Phase 1 study has been carried out in healthy volunteers using a range of non-smoked pharmaceutical drug delivery technologies.
Dr Geoffrey Guy, Chairman of GW Pharmaceuticals, said, "These are the first studies in which human subjects have been administered fully standardised extracts of cannabis. I am pleased to report that the progress of our development programme from the laboratory to human clinical dosing has proceeded without problems. We have tested a number of non-smoked routes of delivery as well as a range of extracts with different cannabinoid ratios. The results of the study will enable us to select the optimal candidate formulations for use in our forthcoming Phase 2 patient studies, subject to approval from the MCA (Medicines Control Agency)." The eventual aim of the clinical development programme is to prepare data for Product Licence Approval. In the event of a Licence being granted, the Home Office has indicated it would be willing to change the Misuse of Drugs Act 1971 to allow the prescribing of a cannabis-based medicine. Dr Guy added, "There is a considerable body of evidence to suggest that cannabis may have a number of medicinal uses, including the relief of pain and spasm in multiple sclerosis, and for pain relief in other neurological disorders, such as spinal cord injury and neuralgia. Our clinical programme will be evaluating these and other uses over the next two to three years in some 2000 patients. Subject to the necessary regulatory approvals, we hope to have a cannabis-based medicine available for prescription by doctors within three to four years."