Newest evidence for THC (tetrahydrocannabinol): cannabidiol oromucosal spray from randomized clinical trials

Neurodegener Dis Manag. 2019 Jan 18. doi: 10.2217/nmt-2018-0050. 

Marková J1.

Author information

Abstract

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 EMA's risk management plan, found no effect of THC:CBD spray on cognition and mood after 50 weeks of treatment. In the Sativex® as add-on therapy versus further optimized first-line ANTispastics (SAVANT)  study, add-on THC:CBD spray was significantly more effective than readjusting standard antispasticity therapy and provided new evidence of efficacy as requested by German authorities. SAVANT results support practical recommendations for treating resistant multiple sclerosis spasticity in daily practice.

KEYWORDS:

THC: CBD oromucosal spray; cognition; mood; multiple sclerosis spasticity; randomized controlled trials; treatment optimization

PMID:

 

30657024

 

DOI:

 

10.2217/nmt-2018-0050

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