GWP.L Regulatory News (GWP)

12 Nov 2007 07:01

GW Pharmaceuticals PLC12 November 2007 New Published Study Shows Sativex(R) Successfully Treats Neuropathic Pain Porton Down, UK, 12 November 2007 - GW Pharmaceuticals plc (AIM: GWP) todayannounces that The International Association of the Study of Pain has publishedonline the results of a study in its official journal Pain, showing that Sativex(R) successfully treats peripheral neuropathic pain1. The trial was a multi centre, double-blind, randomised, placebo-controlledparallel group study, conducted in 125 patients with peripheral neuropathic paincharacterised by allodynia. The publication of these data follows the previousannouncement of preliminary results of this study. In the study, Sativex demonstrated significant superiority to placebo inreducing pain, as measured on a 0-10 Numeric Rating Scale (p=0.004), the primaryendpoint of the study. Statistically significant improvements were also seen inthe Neuropathic Pain Scale composite score (p=0.007), sleep disturbance (p=0.001), dynamic allodynia (p=0.042), punctate allodynia (p=0.021), PainDisability Index (p=0.003) and Patients Global Impression of Change (p< 0.0001). Sativex was well-tolerated in this study, with the majority of adverse eventsbeing mild or moderate. There were no treatment-related serious adverse events. The five week trial was conducted in patients who were experiencing significantlevels of neuropathic pain and who had failed to gain adequate relief fromcurrently available analgesic medications. Patients enrolled in the studycontinued to take their existing medication throughout the trial. Sixty-ninepercent of patients were taking opioid analgesics. Hence, improvements obtainedon Sativex were over and above those obtained on currently available treatments. Professor Turo Nurmikko, Principal Investigator, Professor of Pain Science andConsultant Pain Physician at the Walton Centre for Neurology and Neurosurgery,Liverpool, commented, "Peripheral neuropathic pain can be extremely disablingand is one of the most difficult types of chronic pain to treat. This studydemonstrates that Sativex is effective in the relief of peripheral neuropathicpain. In particular, considering the refractory nature of their pain and thatpatients remained on their existing analgesia, the improvements seen on Sativexare very encouraging." Dr Stephen Wright, Director of Research & Development at GW, noted "We arepleased that this important study has been published in Pain, a highly regardedand influential journal. This recognition of the high quality of GW clinicalresearch and of the importance of these findings provides further evidence ofthe utility of Sativex in the relief of neuropathic pain, an area of significantunmet medical need." This study is part of a broad programme of clinical trials aimed at securingfuture regulatory approval for Sativex in neuropathic pain. It is intended toconduct further Phase III clinical trials targeted at neuropathic pain followinginitial regulatory approval for Sativex in Multiple Sclerosis in Europe. - ends - Enquiries: GW Pharmaceuticals plc Today: +44 (0)20 7831 3113Dr Geoffrey Guy, Executive ChairmanJustin Gover, Managing DirectorDr Stephen Wright, R&D Director Financial Dynamics Tel: +44 (0)20 7831 3113David Yates, Ben Atwell Notes to Editors Sativex(R) Sativex (THC:CBD), an endocannabinoid system modulator, is derived from wholeplant extracts of two specifically bred cannabis plant varieties. The extractsare combined to produce a standardised formulation containing two majorcomponents of cannabis, the cannabinoids -tetrahydrocannabinol (THC) andcannabidiol (CBD). Sativex is formulated into a pump action oromucosal (mouth) spray designed forself-administration by the patient. This formulation allows for flexibledosing, ideal for the variable nature of MS. Each spray of Sativex delivers afixed dose of 2.7mg THC and 2.5mg CBD. Sativex was generally well tolerated inthe study. Allodynia Allodynia is the occurrence of pain in response to a normally non-painfulstimulus (e.g. clothes touching against the skin). It is often intense and canoccur in patients suffering from a range of conditions that damage theperipheral nerves (e.g. diabetes, post-herpetic neuralgia) and is a highlyreliable marker of neuropathic pain. Neuropathic pain can be difficult todiagnose and may be confused with nociceptive pain (caused by bodily injury - 'visceral' or 'somatic'). The presence of allodynia can confirm that the painexperienced by the patient is truly neuropathic. Neuropathic Pain Neuropathic pain is caused by damage to or dysfunction of the nervous system. Itis usually chronic and accompanied by unpleasant burning or shooting sensations,or extreme sensitivity to touch. The classification of central or peripheralneuropathic pain is determined by the location of the damage or dysfunction inthe nervous system. It is estimated that at least 1 per cent. of the world's population suffers fromneuropathic pain, including over 600,000 patients in UK. Neuropathic pain can be associated with many conditions including multiplesclerosis, stroke, cancer, spinal cord injury, physical trauma and peripheralneuropathy resulting from diabetes. It can also occur in patients who havepreviously suffered from shingles, a condition known as post-herpetic neuralgia. Neuropathic pain is one of the most difficult types of chronic pain to treat.Since treatment options are limited, doctors often prescribe a combination oftherapies in an attempt to relieve symptoms. GW Pharmaceuticals plc GW was founded in 1998 and listed on the AIM, a market of the London StockExchange, in June 2001. Operating under license from the UK Home Office, thecompany researches and develops cannabinoid pharmaceutical products thatalleviate pain and other neurological symptoms in patients who suffer fromserious ailments. GW has assembled a team of over 100 scientists with extensive experience indeveloping both plant-based prescription pharmaceutical products and medicinescontaining controlled substances. GW occupies a world leading position incannabinoids and has developed an extensive international network of the mostprominent scientists in the field. For further information, please visitwww.gwpharm.com References 1. Nurmikko T, Serpell M, et al. Sativex Successfully Treats Neuropathic PainCharacterised by Allodynia: a Randomised, Double-Blind, Placebo-ControlledTrial. Pain. 2007: doi:10.1016/j.pain.2007.08.028 This information is provided by RNS The company news service from the London Stock Exchange