A withdrawal trial does not provide evidence to support maintenance of benefit from nabiximols for spasticity.
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 3.6 years of treatment before baseline. After completing a 7-day baseline spasticity-rating diary while …
Reviewing Author
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)