The cannabidiol Sativex® has shown further positive anti-spasticity results in patients with multiple sclerosis in a Phase III clinical trial.
The findings showed that about half of all people with moderate to severe spasticity due to multiple sclerosis (MS) who have responded inadequately to standard anti-spasticity therapy, experienced better control of spasticity with the addition of Sative oromucosal spray (delta-9-tetrahydrocannabinol [THC] and cannabidiol [CBD]), to their existing medication.
The primary efficacy endpoint was the change in a validated, 10 point (0-10) self-reported spasticity numerical rating scale (NRS) from the point of randomisation to the end of the treatment.
Sativex® was shown to provide significant improvement, compared to placebo, in the NRS spasticity score, spasm frequency and sleep disturbance related to spasticity.
After a four-week, single-blind therapeutic trial period in 572 patients, Sativex® reduced the mean NRS score for spasticity by 3.01 points, from a baseline of 6.91 points.
The results, published online in the European Journal of Neurology Early View, showed that 48% of patients achieved a clinically meaningful improvement of ≥20% in spasticity severity during this initial period.
Of these responders, 241 proceeded into a 12-week, randomised, placebo-controlled trial phase.
At the end of the trial, Sative had reduced the mean spasticity 0-10 NRS score in responders by significantly more than placebo (estimated treatment difference 0.84 points; p=0.0002).
The number of patients achieving an improvement in spasticity NRS of ≥30% by the end of the trial was significantly greater in the Sativex group than the placebo group (74% vs. 51%; p=0.0003).
Professor John Zajicek, Honorary Consultant in Neurology, Derriford Hospital and Chair of Clinical Neurosciences at Peninsula College of Medicine and Dentistry, University of Plymouth said: “We have been aware for a long time that cannabinoid medicines can significantly improve spasticity, which is a common, complex symptom of MS, and now the results from this study prove the positive impact they can have on patients’ symptoms, and ultimately their lives.”