The first clinical trials of cannabis-based medicines involving patients suffering from MS, spinal cord injury and other forms of severe pain and spasticity have been given permission to proceed by the UK medical authorities. GW Pharmaceuticals, the company licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop prescription cannabis-based medicines, will commence these Phase 2 trials in the near future.
Dr Geoffrey Guy, Chairman of GW Pharmaceuticals, said, "Entering Phase 2 trials is a highly significant point in the development of cannabis-based medicines. These trials will allow us to demonstrate efficacy in a limited number of subjects and to establish the necessary dosage regimen and delivery mechanisms to provide the most effective relief to sufferers from the acute pain and spasticity associated with MS and other neurological disorders." GW has been granted a clinical trial exemption certificate (CTX) by the Medicines Control Agency (MCA). The CTX is a requirement for any pharmaceutical company wishing to carry out patient studies in the UK. The trials, to be conducted at a number of locations, will commence in the Pain Relief Clinic at the James Paget Hospital, Great Yarmouth, under the supervision of Dr Willy Notcutt. Dr Notcutt said, "Our aim is to test some of the claims which have been made for the medicinal qualities of cannabis in a structured clinical research programme. This is an exciting moment, and we hope very much that our findings will lead to significant improvements in the pain relief available for sufferers of MS and other debilitating conditions." Patients will take different formulations of cannabis-based medicines by means of a sub-lingual spray device - it is sprayed under the tongue and absorbed, rather than swallowed. Initially, a limited number of patients will take part; but as data is collected and analysed the trials will be extended. It is anticipated that over the next two to three years some 2000 patients will be involved in the trials programme. Doctors or patients interested in the trials can find out more at www.medicinal-cannabis.org. The aim of GW's clinical development programme is to prepare data for Product Licence Approval. In the event of a Licence being granted, the UK Government has indicated that it would be willing to amend the Misuse of Drugs Act 1971 to allow the prescribing of a cannabis-based medicine. GW hopes to bring to market prescription medicines as early as 2003. This will allow sufferers of MS and other conditions to experience the medical benefits of cannabis without unwanted psychoactive side effects, and without the health dangers associated with smoking. 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 disorders such as spinal cord injury and neuralgia. We are now well on the way to being able to demonstrate this in a controlled clinical research environment."