Abstract

Sativex (nabiximols), an oral/mucosal spray extract of Cannabis sativa containing delta-9-tetrahydrocannabinol and cannabidiol, is approved for treating multiple sclerosis–related spasticity in some European countries. Approval was based on improved scores on a patient-reported spasticity scale in a short, placebo-controlled study in a group of previously identified “responders.” This manufacturer-sponsored withdrawal trial was designed for established users of prescription nabiximols in the U.K., where the healthcare regulatory agency requires proof of efficacy maintenance. The 36 participants were identified as responders over a mean of …

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