Sativex: Cannabis Based Drug

Sativex is licensed in the UK and Canada for MS, cancer and other conditions were pain, spasticity and muscle spasms are common symptoms. Sativex is made from extracts of the cannabis plant, unlike similar pharmaceuticals which are synthetically produced. It is an oral spray which is sprayed under the tongue a number of times a day. It has been licensed in the UK for the treatment of spasticity.

In March 2009 GW Pharmaceuticals announced results of two clinical trials involving Sativex and its effect on spasticity in people with MS. A phase III study involved 573 people with MS who were affected by spasticity and had not responded to existing therapies. Participants in the study were given Sativex for four weeks. Those who responded to the treatment (241 of the original 573 people) continued to be given either Sativex or a placebo (dummy treatment), for a further 12 weeks. Throughout the trial, participants were not allowed to exceed a fixed dose of the medication.

• 74% of people who continued treatment with Sativex achieved an improvement of greater than 30% in their spasticity score compared with 51% of people who were given the placebo treatment


• There were also significant reductions in spasms and sleep disturbances and an improvement in the overall impression of change in the study participants.

Another small study involved 36 people with MS who had been taking Sativex for an average of three and a half years. The participants either continued treatment with Sativex, or were given a placebo treatment for four weeks.  At the end of the study, people on the placebo treatment and their carers reported worsening spasticity compared with people taking Sativex. Although the results have been reported as statistically significant, GW Pharmaceuticals did not indicate by how much spasticity was reduced in people taking Sativex. One of the primary aims of this study was to assess withdrawal symptoms as a result of terminating long-term use of Sativex. Results from this trial have indicated very few withdrawal symptoms as a result of terminating Sativex even after several years use.

MS Ireland believes that people with MS should have access to all medications and interventions that have been deemed safe and effective as a result of rigorous medical trails. In writing to the Minister MS Ireland has outlined the benefits of Sativex as per the published research and has requested the Minister to address the legislature issue and make Sativex available to people with MS.

Extracts taken from www.mssociety.org.uk

Information Sheet on Sativex