Observational Safety Study of THC: CBD Oromucosal Spray (Sativex) in Multiple Sclerosis Patients with SpasticityCelia Oreja-Guevara1*, Bonaventura Casanova2, Carlos Manuel Ordás1, Carlos Vila Silván3, David Asensio3 and Mariona Massana3
2\Neurology Service, Hospital Clínico Universitario “La Fe”, Valencia, Spain
- *Corresponding Author:
- Dr. Celia Oreja-Guevara
Chair of Clinical Research
Multiple Sclerosis Unit, Neurology
University Hospital San Carlos
C/ Profesor Martin Lagos s/n
28040 Madrid, Spain
Tel: +34 652819896
Fax: +34 913303512
Email: [email protected]
Received date: July 03, 2015 Accepted date: July 31, 2015 Published date: August 07, 2015
Citation: Oreja-Guevara C, Casanova B, Ordás CM, Silván CV, Asensio D, (2015) Observational Safety Study of THC: CBD Oromucosal Spray (Sativex) in Multiple Sclerosis Patients with Spasticity. Clin Exp Pharmacol 5:184. doi: 10.4172/2161-1459.1000184
Copyright: © 2015 Oreja-Guevara C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract Background: Subsequent to introduction in June 2010 in the United Kingdom and Spain of tetrahydrocannabinol (THC) : cannabidiol (CBD) oromucosal spray (Sativex®) for management of multiple sclerosis (MS) spasticity, and as part of a wider initiative to address British health authority requirements for post-marketing surveillance to identify possible short- and long-term risks associated with its use as a condition of marketing authorization, studies were undertaken to evaluate the safety of THC: CBDspray under clinical practice conditions. Methods: This prospective, observational, multicentre study reports on 205 patients with treatment-resistant MS spasticity who were prescribed THC: CBD spray as add-on therapy to existing antispasticity medications at 13 specialist MS centres across Spain. Safety evaluations were performed after 6 and 12 months’ exposure to THC: CBD spray. Results: Add-on THC: CBD spray was well tolerated during up to 12 months’ exposure. No new safety signals emerged and THC: CBD spray was not associated with any clinically-relevant occurrence of adverse events of special interest with cannabinoid-based medications such as falls requiring medical attention, psychiatric or psychotic symptoms, memory impairment, changes in driving ability, addiction or abuse. After 6 months’ and 12 months’ exposure, treating physicians considered that 139 patients (68% of original cohort) and 124 patients (60.5% of original cohort), respectively, were deriving sufficient anti-spasticity benefit from THC: CBD spray to warrant continued treatment. The mean dosage of THC: CBD spray (6.6 sprays/day) and carer requirements (~14.5 hours/day) remained stable throughout the study. Conclusions: THC: CBDspray as add-on therapy showed good tolerability and sustained anti-spasticity benefit in a relevant proportion (60.5%) of Spanish patients with MS-related spasticity treated for up to 12 months in everyday clinical practice.