GWP.L Regulatory News (GWP)

17 Mar 2006 07:03

GW Pharmaceuticals PLC17 March 2006 GW PHARMACEUTICALS PLC ("GW" or "the Company") PRELIMINARY RESULTS FROM SATIVEX(R) PHASE III MULTIPLE SCLEROSIS SPASTICITY STUDY GW to evaluate optimal regulatory filing strategy with marketing partners Porton Down, UK, 17 March 2006 - GW Pharmaceuticals plc (AIM: GWP) todayannounces preliminary results from a Phase III study of Sativex(R) in the reliefof spasticity in people with Multiple Sclerosis (MS). This study is one of anumber of Phase III studies which are currently taking place to support approvalof Sativex across Europe in a range of target indications. Analysis of the per protocol population (those patients that complied with thestudy protocol) showed a positive and statistically significant improvement inthe primary outcome measure (p0.05). Dr Stephen Wright, R&D Director at GW, said: "The study supports the significant positive data already generated fromprevious GW studies in people with MS who have failed to respond to currentlyavailable anti-spasticity treatments. This is a high need patient population andwe are considering the regulatory impact of this new study in light of thedifferent outcomes of the two statistical analyses and in the context of ouroverall regulatory strategy for Sativex. Whilst this study may provide GW with aregulatory route in Europe for the spasticity indication, the bulk of ourpositive clinical data relates to neuropathic pain. We have two further PhaseIII neuropathic pain studies due to report later this year and we need toconsider with our marketing partners the relative benefits of awaiting that databefore submitting the next regulatory filing." The trial reported today was a randomized placebo-controlled parallel groupstudy in 335 people with spasticity due to MS. All patients entering the studywere taking best available anti-spasticity medication and remained on suchmedication through the trial. Hence, any improvements seen in the trial wereobtained over and above currently available treatment. The primary outcomemeasure was the improvement in spasticity as measured on a 0-10 numeric ratingscale. The duration of treatment in the study was 14 weeks. In this trial, the primary endpoint, and two key secondary endpoints (theResponder Analysis and the Carer Global Impression of Change), in the perprotocol analysis achieved statistical significance, whereas the outcomes in theITT analysis were positive but non-significant. The lack of significance in theITT analysis was not due to a lack of effect of Sativex, but rather was due to alarger than expected placebo response, thus reducing the size of the differencebetween the two groups. Had the placebo response been the same as in GW'sprevious completed Phase III spasticity study, the ITT analysis in this newstudy would also have been statistically significant. Separately, a pooled analysis across the three Sativex MS spasticity studies nowcompleted, incorporating a total of 652 patients, shows Sativex to besignificantly superior to placebo (p