title: Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years.
abstract: BACKGROUND
  In Italy, all prescriptions for THC:CBD oromucosal spray for treatment of multiple sclerosis (MS) spasticity are linked to the official Agenzia Italiana del Farmaco (AIFA) web-based registry, which tracks the effectiveness and tolerability of medications in a prospective and observational manner.
  
  
  METHODS
  AIFA e-registry data for THC:CBD oromucosal spray collected between January 2014 and February 2015 for 1,534 patients from 30 large Italian specialized MS centres were compiled. Patients had a long disease history (17.6 ± 8.6 years) and significant impairment (mean Expanded Disability Status Scale score 6.4 ± 1.2). MS spasticity was evaluated using the 0-10 numerical rating scale (NRS).
  
  
  RESULTS
  After the first month titration and trial period, 61.9% of patients achieved sufficient improvement in spasticity (≥20% NRS) to qualify for continued treatment. After 6 months, clinically meaningful ≥30% NRS improvement was recorded in 40.2% of patients continuing with treatment. Spasticity-associated symptoms such as cramps and nocturnal spasms improved in most responding patients. Mean reported doses of THC:CBD oromucosal spray (6.2-6.7 sprays/day) were lower than those reported in clinical trials. Adverse events (mainly mild to moderate) were reported by 15% of patients; no new safety concerns beyond the approved label were identified.
  
  
  CONCLUSIONS
  The results of the AIFA e-registry analysis align with those of other THC:CBD observational projects and reaffirm the characteristics of this therapeutic option in the management of treatment-resistant MS spasticity, a frequently overlooked symptom.
authors.affiliation: Department G.F. Ingrassia, Section of Neurosciences, University of Catania, Catania, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Patti
mesh_terms: D000328:Adult; D002185:Cannabidiol; D003625:Data Collection; D013759:Dronabinol; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D064086:Medical Marijuana / Q000627:therapeutic use*; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy*; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D058993:Oral Sprays; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D064086:Medical Marijuana; D058993:Oral Sprays; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols