GWP.L Regulatory News (GWP)

15 Jan 2007 07:01

GW Pharmaceuticals PLC15 January 2007 Results of Sativex(R) Phase III Neuropathic Pain Trials Demonstrate Benefits for High Need Treatment-Resistant Patients 15 January 2007: GW Pharmaceuticals plc ("GW") today announces preliminaryresults of two Phase III studies of Sativex(R), its cannabinoid spray medicine,in peripheral neuropathic pain. These studies are part of a programme togenerate data for the future expansion of the use of Sativex in Europe beyondMultiple Sclerosis (MS) into other pain conditions. The results of the study in patients with neuropathic pain characterised byallodynia show that patients taking Sativex obtain clinically importantimprovements in their management of pain and quality of sleep. In comparisonwith placebo, statistically significant improvements were seen for key outcomemeasures, including a positive result in the primary analysis of patientresponse, the outcome measure recommended by regulatory authorities. The results of the study in patients with painful diabetic neuropathy show thatpatients taking Sativex obtained substantial improvements in their pain, indeedamong the highest level of response seen in the published literature. There wasan abnormally large placebo response in this study, which means that the dataare more difficult to interpret categorically. Dr Stephen Wright, GW's R&D Director, said, "Neuropathic pain is one of the mostdifficult types of chronic pain to treat. These studies focused on particularlyhigh need patients, who were already taking the best available pain treatments,and yet still suffered severe pain. Even in this most difficult to treatpopulation, Sativex has produced improvements over and above current treatmentsthat are highly meaningful to the everyday lives of patients." These two studies form part of a programme of neuropathic pain trials conductedto date by GW and reinforce the large body of positive data already generated.These data contribute significantly to a future regulatory filing in the use ofSativex as a treatment for neuropathic pain. GW intends to continue to add tothis evidence base. Allodynia Study This multi-centre double-blind, randomised, placebo-controlled parallel groupstudy in 246 patients examined the effect of Sativex in patients withneuropathic pain characterised by allodynia. Allodynia is the occurrence of painin response to a normally non-painful stimulus (e.g. clothes touching againstthe skin). It is often intense and can occur in patients suffering from a rangeof conditions that damage the peripheral nerves (e.g. nerve lesions,post-herpetic neuralgia). Patients in this study were being treated with a rangeof currently available analgesics, which were maintained during the course ofthe study. The results of this study confirm the efficacy of Sativex. The responderanalysis of the primary endpoint (the proportion of patients obtaining aclinically meaningful improvement in pain relief), was statisticallysignificantly in favour of Sativex (p=0.03) for the full Intention to Treat(ITT) population. In addition, two of the key pain-related secondary efficacyendpoints, the Patient's Global Impression of Change (p