Sativex
Purposeaim To evaluate the efficacy of tetrahydrocannabinol (THC)cannabidiol (CBD) oromucosal spray (Sativex Sativex Of 191 patients who entered Phase A, 106 were randomised in Phase B to receive add-on THCCBD spray (n 53) or placebo (n 53). The proportion of clinically relevant responders after 12 weeks (≥30% NRS improvement primary efficacy endpoint) was significantly greater with THCCBD spray than placebo (77.4 vs. 32.1% p < 0.0001). Compared with placebo, THCCBD spray also significantly improved key secondary endpoints changes in mean spasticity NRS (p < 0.0001), mean pain NRS (p 0.0013), and mean modified Ashworths scale (p 0.0007) scores from Phase B baseline to week 12. Adverse events, when present, were mildmoderate and without new safety concerns. Add-on THCCBD oromucosal spray provided better and clinically relevant improvement of resistant MS spasticity compared with adjusting first-line antispasticity medication alone.