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.
- 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
Z farmaceutického a medicínského hlediska je konopí seté zajímavý a perspektivní materiál. Obsahuje biologicky aktivní kanabinoidy, jejichž izolace a identifikace v 60. letech 20. století umožnily bouřlivý výzkum, který přináší i v dnešní době zajímavé poznatky. Jedná se především o odhalování lidské fyziologie endokanabinoidního systému a farmakologických účinků kanabinoidů či odvozených syntetických látek. Dále se vývoj ubírá k lékovým formám s vhodnou cestou podání a farmakokinetickými parametry pro využití v klinické praxi. Kanabinoidy otevírají zcela nové cesty ovlivnění řady závažných lidských chorob a mohou se tak stát perspektivní skupinou potenciálních léčiv. Tento přehledový článek uvádí účinky kanabinoidů v souvislosti s ovlivněním endokanabinoidního systému, jejich využití ve farmakoterapii, nežádoucí účinky, interakce s ostatními léky a používané lékové formy. Doplňkově jsou také zmíněny související zákony platné v České republice, doplněné forenzními metodami detekce kanabinoidů.
From the pharmaceutical and medicinal point of view Cannabis sativa L. is an interesting and perspective material. It contains biologically active cannabinoids whose isolation and identification in the 1960's enabled a rapid research that has been bringing interesting results to this day. Especially revealing the human endocannabinoid system and the pharmacological effects of cannabinoids or derived synthetic compounds are the most interesting areas. The research in this field continues also toward pharmaceutical dosage forms with convenient route of administration and pharmacokinetics parameters to be used in clinical practice. Cannabinoids open completely new approaches in the treatment of many relevant human diseases and can become perspective and potential remedies. This review article deals with the effects of cannabinoids on human endocannabinoid system, their use in pharmacotherapy, their adverse effects, their interactions with other drugs and the convenient pharmaceutical dosage forms. Additional information concerning laws valid in the Czech Republic and used analytical forensic methods of cannabinoids are reviewed here as well.
- MeSH
- Cannabis drug effects MeSH
- Drug Therapy methods utilization MeSH
- Financing, Organized MeSH
- Cannabinoids administration & dosage adverse effects therapeutic use MeSH
- Drug and Narcotic Control methods legislation & jurisprudence MeSH
- Drug Interactions physiology genetics immunology MeSH
- Humans MeSH
- Cannabinoid Receptor Modulators administration & dosage adverse effects therapeutic use MeSH
- Drug-Related Side Effects and Adverse Reactions complications MeSH
- Receptors, Cannabinoid administration & dosage therapeutic use drug effects MeSH
- Drug Administration Schedule MeSH
- Legislation, Drug standards trends MeSH
- Check Tag
- Humans MeSH
- Geographicals
- Czech Republic MeSH
