GW Pharmaceuticals plc is the company licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked prescription cannabis-based medicines. We hope to bring to market our first prescription medicine in early 2004. This will provide sufferers of multiple sclerosis and other neurological disorders with a medicine which allows them to experience the medical benefits of cannabis without unwanted psychoactive side effects, and without the health dangers associated with smoking.
Phase Three of our UK trials programme, currently underway, is the largest such study undertaken to date by GW and involves over 500 patients. Our aim is to prepare data for Product Licence Approval by the Medicines Control Agency. In the event of a Licence being granted, the Home Secretary has confirmed that he would be willing to amend the Misuse of Drugs Act 1971 to allow the prescribing of a cannabis-based medicine.
Patients in our various trials are taking 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. This device is designed to deliver the drug principally to the mucosa for rapid effect. The patients also take an inactive 'placebo'. Neither the researchers nor the patients know whether they are using the active substance or the placebo at any given time.
Our results to date appear to show significant reduction in pain, muscle spasm and bladder dysfunction as well as improved neurological function. In addition, patients are able to self-titrate (adjust) their dose so as to provide the suitable level of medical benefit without incurring unwelcome side effects.
All our medicines are derived from extracts of plants which we grow ourselves. GW benefits from more than 10 years research expertise on cultivation and analysis of the cannabis sativa plant. Our plants are grown in a highly secure glasshouse facility. All aspects of the growing climate – temperature, humidity, air changes and photoperiod – are controlled by computer.
As far as Fibromyalgia is concerned, no specific clinical data exists on cannabis' ability to combat the symptoms of the condition. However, some patients report anecdotally that the drug benefits them. In Iowa, USA, a court judge has allowed a Fibromyalgia patient to use cannabis while on probation to effectively treat his chronic pain.
It does seem likely that cannabis alleviates some symptoms of Fibromyalgia. Cannabis' potential as an analgesic and anti-inflammatory have been documented by the Institute of Medicine, National Institute of Health, and others.
Additionally, cannabis has a long history as a sleep-inducing drug. One study of fifteen insomniac patients reported that over a five-week period "sleep quality was significantly influenced by 160 mg of cannabidiol (a non-psychoactive cannabinoid) as two-thirds of the subjects slept more than seven hours and … most subjects had few interruptions of sleep." An Italian research team reported that subjects who had inhaled cannabis within the last half-hour had significantly higher melatonin levels than those who abstained. Melatonin, a hormone produced by the pineal gland, is widely used to treat insomnia.
So there is evidence there to be considered. At the same time, there are a significant number of potential uses of cannabis-based medicines, and as a small young research company with limited resources, we have been forced to make choices as to the number of medical conditions we can research. Throughout our short history, this has been a difficult issue for us since we would, of course, wish to explore all potential uses of cannabis-based medicines as soon as we are able. Over the years, we have received letters from over 3,500 patients suffering from a very wide range of conditions, including Fibromyalgia. We have used this correspondence as an indicator of the priorities which we should attach to our research. Hence, for the time being, we have focused on patients suffering from multiple sclerosis, spinal cord injury and general neuropathic pain. In due course, as research in one area comes to a conclusion, we will broaden the scope of our research, and Fibromyalgia is certainly a condition we will consider.
Right now, our over-riding priority is to ensure that the first cannabis-based medicine is approved by the Medicines Control Agency as soon as possible so that it can be prescribed by doctors to patients. This will be the first cannabis-based medicine approved anywhere in the world. It is worth noting that although this cannabis-based medicine will be approved at that time for a specific use, it will be possible for the medicine to be prescribed by doctors (at their own discretion) for patients with other conditions.
At GW, we are all too aware that there are a large number of patients suffering from a broad range of medical conditions who may benefit from cannabis-based medicines. We are dedicated to finding a means for as many of such patients as possible to have access to these medicines in the shortest possible timeframe.
(This area of research will be worth monitoring for its success and possible future research funding here in the UK for use with fibromyalgia. Editor) |
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