Porton Down, UK, 3 October 2006 – GW Pharmaceuticals plc (AIM: GWP) announces today that results from two Phase III studies of Sativex ® were presented at Europe's leading multiple sclerosis (MS) conference, the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis ( ECTRIMS), which took place in Madrid, Spain, from 27 - 30 September. The outcome of the studies in spasticity and bladder dysfunction, both symptoms of MS, were first reported by GW earlier this year.
The MS spasticity study, which evaluated 337 patients over a 15 week period, showed a significant reduction in symptoms of spasticity in patients in the ‘per protocol' population (i.e. those patients who complied with the study protocol) with advanced MS who had severe levels of spasticity despite ongoing treatment with the best available anti-spasticity medications. In addition 36% of these patients reported at least a 30% improvement in their spasticity symptoms which was also statistically significant 1 . The ‘intention to treat' population (all patients who entered the study, some of whom may have violated the protocol) showed a trend towards Sativex but this did not reach statistical significance. Sativex-treated patients also reported improvements in secondary endpoints such as sleep assessments at clinic visits; a timed 10 metre walk, quality of life measures, spasm severity and bladder symptoms. Benefits were also reported by carers who noticed overall improvements in the Sativex group.
Professor Christine Collin, lead investigator in the study and Consultant in Neurological Rehabilitation Medicine based at The Royal Berkshire and Battle NHS Trust, Reading commented, “This study shows encouraging results in a patient population with a high level of unmet medical need. It demonstrates that Sativex can reduce spasticity in these difficult to treat patients who have failed to gain enough improvement in their spasticity from the best currently available medication. Furthermore, when these results are pooled with a previous similar trial giving a total population of over 520 MS patients with spasticity, significant benefits in favour of Sativex were seen, in the whole intention to treat population.”
A second Phase III study presented at ECTRIMS and short-listed for a prize by the scientific committee, investigated Sativex in the management of bladder problems in people with MS. Bladder problems are a very common feature in up to 75% of people with MS experiencing dysfunction including increased frequency and urgency of urination and increased incontinence2. This study in 135 patients suffering with urinary incontinence, not wholly relieved by their existing treatment, demonstrated that Sativex had a positive impact on the symptoms of over-active bladder with 84% in the Sativex treated group vs. 58% of the placebo group reporting improvements in bladder dysfunction3. Statistically significant improvements were seen in nocturia (urination during the night), number of voids per day and patients' opinion of bladder symptom severity.
Sativex contains the cannabinoids 9 -tetrahydrocannabinol (THC) and cannabidiol (CBD) and is formulated as an oromucosal spray which is administered by spraying into the mouth and allows flexible dosing which is ideally suited to the variable nature of MS. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. Sativex was generally well tolerated in both studies 1,3.
Sativex is licensed in Canada and has recently been submitted for regulatory approval in selected European countries.
GW Pharmaceuticals plc
Dr Geoffrey Guy, Executive Chairman Tel: + 44 (0)1980 557000
Justin Gover, Managing Director
Financial Dynamics Tel: +44 (0)20 7831 3113
David Yates, Sarah MacLeod
Notes to Editors
About GW Pharmaceuticals plc
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under licence from the UK Home Office, the Company is developing cannabis-derived pharmaceutical products for patients with multiple sclerosis, neuropathic pain, cancer pain, spinal cord injury, rheumatoid arthritis, and other severe medical conditions.
GW has assembled a team of over 100 scientists with extensive experience in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW is dedicated to developing treatment options that alleviate pain and other neurological symptoms in patients who suffer from serious ailments.
For further information, please visit the Company's website:www.gwpharm.com.
1. Collin C, Ambler Z et al. A randomised study of Sativex® in patients with symptoms of spasticity due to multiple sclerosis. Poster 412 presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)
3. de Ridder D, Constantinescu C et al. Randomised controlled study of cannabis based medicine (Sativex®) in patients suffering from multiple sclerosis associated detrusor overactivity. Poster 411 presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)