Sativex and MS in the UK

GW Pharmaceuticals have released the results of their Phase III trials using the cannabis extract Sativex with 335 people with spasticity due to MS.

The company said multiple sclerosis patients who followed the trial’s protocols did benefit. But an analysis of all study participants - whether or not they complied to the protocol – found no statistically significant advantage compared with a placebo.

The low significance in the results for patients not complying with the protocol was not due to a lack of effect of Sativex, but to a larger than expected placebo response. Had the placebo response been the same as in GW’s previous completed Phase III spasticity study, the results for these patients would also have been statistically significant.

All patients in the study continued to take their existing best-available medication, so any improvements seen in the trial were obtained over and above currently available treatment.

Separately, a pooled analysis across the three Sativex MS spasticity studies now completed, incorporating a total of 652 patients, shows Sativex to be significantly superior to placebo.

Nevertheless, Sativex may earn earlier approval for its benefit in treating neuropathic pain: "Most consistently positive data we have seen previously has been in neuropathic pain, so we are certainly quietly optimistic," said the research and development director, Stephen Wright.

Sources:
GW Pharmaceuticals
International Association for Cannabis as Medicine
The Guardian newspaper