Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from postapproval pragmatic studies.

Abstract

Postapproval studies have an essential role in demonstrating that an intervention is effective and well tolerated during use in daily clinical practice. Numerous large observational and registry studies of tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray have been conducted subsequent to its approval in Europe in 2011. Collectively, these studies provide valuable insight into various aspects of THC:CBD spray during real-world use in patients with multiple sclerosis spasticity, including its long-term effectiveness and tolerability. The Italian Medicines Agency's web-based registry is the largest observational study of THC:CBD oromucosal spray conducted to date, reporting on more than 1600 patients prescribed THC:CBD spray since it was introduced in Italy in 2013, and further supporting its effectiveness and tolerability profile.

• Authors: Francesco Patti
• Journal: Neurodegenerative disease management (Neurodegener Dis Manag) Vol. 9 Issue 2s Pg. 3-7 (04 2019) ISSN: 1758-2032 [Electronic] England
• PMID: 30657027 (Publication Type: Journal Article)

Chemical References

• Cannabinoid Receptor Modulators
• Drug Combinations
• Oral Sprays
• Cannabidiol
• Dronabinol
• nabiximols

Topics

• Administration, Mucosal
• Cannabidiol (administration & dosage, pharmacology)
• Cannabinoid Receptor Modulators (administration & dosage, pharmacology)
• Dronabinol (administration & dosage, pharmacology)
• Drug Approval
• Drug Combinations
• Humans
• Italy
• Multiple Sclerosis (complications, drug therapy)
• Muscle Spasticity (drug therapy, etiology)
• Observational Studies as Topic
• Oral Sprays
• Pragmatic Clinical Trials as Topic
• Registries