Health Authorities Data Collection of THCCBD Oromucosal Spray (LAgenzia Italiana del Farmaco Web Registry) Figures after 1.5 Years.
In Italy, all prescriptions for THCCBD 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. AIFA e-registry data for THCCBD 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). 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 THCCBD oromucosal spray (6.2-6.7 spraysday) 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. The results of the AIFA e-registry analysis align with those of other THCCBD observational projects and reaffirm the characteristics of this therapeutic option in the management of treatment-resistant MS spasticity, a frequently overlooked symptom.