Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials
Language English Country Great Britain, England Media print-electronic
Document type Journal Article
PubMed
30657024
DOI
10.2217/nmt-2018-0050
Knihovny.cz E-resources
- Keywords
- THC:CBD oromucosal spray, cognition, mood, multiple sclerosis spasticity, randomized controlled trials, treatment optimization,
- MeSH
- Affect drug effects MeSH
- Administration, Mucosal MeSH
- Drug Combinations MeSH
- Cannabidiol administration & dosage pharmacology MeSH
- Cognition drug effects MeSH
- Humans MeSH
- Cannabinoid Receptor Modulators administration & dosage pharmacology MeSH
- Randomized Controlled Trials as Topic * MeSH
- Multiple Sclerosis complications drug therapy MeSH
- Muscle Spasticity drug therapy etiology MeSH
- Dronabinol administration & dosage pharmacology MeSH
- Oral Sprays MeSH
- Outcome and Process Assessment, Health Care * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Drug Combinations MeSH
- Cannabidiol MeSH
- Cannabinoid Receptor Modulators MeSH
- nabiximols MeSH Browser
- Dronabinol MeSH
- Oral Sprays MeSH
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.
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