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Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials
J. Marková,
Language English Country Great Britain
Document type Journal Article
NLK
PubMed Central
from 2015 to 1 year ago
ProQuest Central
from 2011-02-01 to 2021-02-28
Nursing & Allied Health Database (ProQuest)
from 2011-02-01 to 2021-02-28
Health & Medicine (ProQuest)
from 2011-02-01 to 2021-02-28
Psychology Database (ProQuest)
from 2011-02-01 to 2021-02-28
PubMed
30657024
DOI
10.2217/nmt-2018-0050
Knihovny.cz E-resources
- 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
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.
References provided by Crossref.org
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