GW Pharmaceuticals' Phase III clinical study of Sativex Oromucosal Spray (delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)) in multiple sclerosis (MS) spasticity demonstrated that as add-on treatment it can improve the debilitating symptoms of spasticity associated with MS in patients who have not responded adequately to standard anti-spasticity therapy.
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The study is a 19-week follow-up, multicentre, double-blind, randomised, placebo-controlled, parallel-group study in subjects with MS spasticity not fully relieved with current anti-spasticity therapy.
The trial result suggested that in the trial Sativex showed improvement, compared to placebo, in the NRS spasticity score, spasm frequency and sleep disturbance related to spasticity.
GW Pharma said that Sativex showed reduction in the mean NRS score for spasticity by 3.01 points, from a baseline of 6.91 points. 48% of patients achieved a clinically meaningful improvement of =20% in spasticity severity after four-week.
University of Plymouth Honorary Consultant in Neurology John Zajicek said they 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.
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