Newest evidence for tetrahydrocannabinolcannabidiol oromucosal spray from randomized clinical trials.
Subsequent to EMA approval of tetrahydrocannabinol (THC) cannabidiol (CBD) oromucosal spray based on results of various studies, including an enriched-design clinical trial, two newer postapproval randomized trials have confirmed its efficacy and safety for treating resistant multiple sclerosis spasticity, while simultaneously addressing specific authorities concerns. A double-blind, placebo-controlled, Phase IV trial, conducted as part of the EMAs risk management plan, found no effect of THCCBD spray on cognition and mood after 50 weeks of treatment. In the Sativex