On 20 July the British company GW Pharmaceuticals announced that it has withdrawn its current regulatory application for Sativex in Europe for the treatment of spasticity in patients with multiple sclerosis. It expects to resubmit an application for approval either for spasticity or for neuropathic pain in MS in 2008. This decision followed discussions with regulatory authorities.

In September 2006, GW filed an application for Sativex under the decentralised procedure in four European countries (UK, Spain, Denmark, Netherlands). So far, GW has been able to resolve most of the questions raised by the regulators during this process except one, which requires the conduction of an additional study. The current regulatory application process has confirmed that quality and safety data are already sufficient to support a marketing authorisation of Sativex. The regulators have also confirmed that existing efficacy data provide statistically significant evidence and “could in principle lead to a positive risk benefit conclusion”.

In addition, the regulators wish however to be able to identify patients, which are effectively treated by Sativex ("responders"), in the first 4 weeks of treatment and to confirm that the improvements gained by such responders over a further 12 week period is significantly greater than placebo.

More at: http://www.gwpharm.com

(Source: Press release by GW Pharmaceuticals of 20 July 2007)