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Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials.
Neurodegener Dis Manag. 2019 04; 9(2s):9-13.ND

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.

Authors+Show Affiliations

Neurology Department, Charles University, 3rd Faculty of Medicine and Thomayer Hospital, Czechia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30657024

Citation

Marková, Jolana. "Newest Evidence for Tetrahydrocannabinol:cannabidiol Oromucosal Spray From Randomized Clinical Trials." Neurodegenerative Disease Management, vol. 9, no. 2s, 2019, pp. 9-13.
Marková J. Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials. Neurodegener Dis Manag. 2019;9(2s):9-13.
Marková, J. (2019). Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials. Neurodegenerative Disease Management, 9(2s), 9-13. https://doi.org/10.2217/nmt-2018-0050
Marková J. Newest Evidence for Tetrahydrocannabinol:cannabidiol Oromucosal Spray From Randomized Clinical Trials. Neurodegener Dis Manag. 2019;9(2s):9-13. PubMed PMID: 30657024.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials. A1 - Marková,Jolana, Y1 - 2019/01/18/ PY - 2019/1/19/pubmed PY - 2020/8/19/medline PY - 2019/1/19/entrez KW - THC:CBD oromucosal spray KW - cognition KW - mood KW - multiple sclerosis spasticity KW - randomized controlled trials KW - treatment optimization SP - 9 EP - 13 JF - Neurodegenerative disease management JO - Neurodegener Dis Manag VL - 9 IS - 2s N2 - 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. SN - 1758-2032 UR - https://www.unboundmedicine.com/medline/citation/30657024/Newest_evidence_for_tetrahydrocannabinol:cannabidiol_oromucosal_spray_from_randomized_clinical_trials_ L2 - https://www.futuremedicine.com/doi/10.2217/nmt-2018-0050?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -