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. Conclusion: 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.

Daily Practice Managing Resistant Multiple Sclerosis Spasticity With Delta-9-Tetrahydrocannabinol: Cannabidiol Oromucosal Spray: A Systematic Review of Observational Studies

“…The main focus of the registries was to gather safety data and information on dosages used in everyday clinical practice 31,41 with the exception of the mandatory e-registry of the AIFA which also documented effectiveness data. 32,33…”

“…The duration of drug exposure differed in the registries and NISs (Table 2). The follow-up period in the registries ranged from 6 32,34 to 12 months, 41 with the longest exposure time being 4.5 years in the international safety registry. 31 In the NIS, the follow-up duration varied from 1 month 44 to 4 years.…”

“…Nausea was seen in about 2% of the patients (Tables 5 and 6). 31-33,35,37-42,48 Most of the AEs were mild to moderate and occurred during the titration phase. Likewise, the incidence of AEs of special interest was low (Table 7).…”

Availability and approval of cannabis‐based medicines for chronic pain management and palliative/supportive care in Europe: A survey of the status in the chapters of the European Pain Federation

“…Data on long‐term safety can be collected by patient registries (Fairman, ). In Italy, all prescriptions for THC/CBD oromucosal spray for treatment of multiple sclerosis 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 (Patti, ). Some Canadian licensed producers have been collecting patient data, and some are now partnering with university‐based researchers to conduct large‐scale observational studies (Lough, ).…”

Whole Organisms or Pure Compounds? Entourage Effect Versus Drug Specificity

“…Interestingly, the scientific basis for the use of cannabis to treat a variety of diseases related to excess or inadequate neuronal synchronization, such as epilepsy, Parkinson's disease, Tourette syndrome, and chronic and neuropathic pain, is probably related to the same biological property that impairs working memory in a dose-dependent manner: the capacity of cannabinoids to desynchronize neuronal activity (Robbe et al, 2006). Working memory impairment is mostly related to THC and can be avoided by mixing it with other cannabinoids and terpenes (Cannabisbased medicines, 2003;Johnson et al, 2013;Koehler, 2014;Maccarrone et al, 2017;Patti, 2016;Rekand, 2014;Sastre-Garriga, Vila, Clissold, & Montalban, 2011;Zettl et al, 2016), as typically for in natura cannabis (Russo, 2011). The antidepressant effects of cannabis (de Mello Schier et al, 2014;Jiang et al, 2005), as well as its use to mitigate the consequences of stroke (Bravo-Ferrer et al, 2017), are likely related to its role in the induction of neurogenesis (Avraham et al, 2014;Jin et al, 2004;Xapelli et al, 2013).…”