The manufacturer of Sativex®, the cannabinoid oromucosal spray, has announced that a phase III study failed to reach statistical significance for pain relief in patients with central neuropathic pain due to Multiple Sclerosis (MS).
The study recruited 339 patients who had failed to get adequate pain relief with existing therapies. Patients were randomised to active treatment or placebo and were followed up for 14 weeks. The primary outcome was a reduction in pain by 30% measured on a 1-10 scale.
Patients taking the active treatment reported a mean reduction in pain of 50%, however this was not statistically different from the [unreported] pain reduction level in the placebo arm. This finding was reflected throughout all of the secondary outcome endpoints.
The announcement highlights a higher than expected response in the placebo arm of the study and also notes a lower than expected rate of adverse reactions to the active treatment in comparison to previous studies.
Action: Despite the positive spin contained in the press release it is apparent that the benefits of this product are marginal. New patients should not be started on this product until a clearer benefit has been demonstrated in trial conditions.
Thanks to PharmaGossip for highlighting this press release