Neurodegenerative Diseases
Conte A. · Vila Silván C.
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Article / Publication Details
Abstract
Background: Sativex (USAN: nabiximols) oromucosal spray is indicated for treatment of multiple sclerosis (MS) patients with moderate to severe spasticity and inadequate response to other antispasticity medications who demonstrate clinically significant improvement during an initial trial of therapy. This narrative review investigated the efficacy and effectiveness of nabiximols oromucosal spray for moderate to severe MS spasticity by examining spasticity 010 Numerical Rating Scale (NRS) data from interventional and observational studies which featured a 4-week trial period as per the European Union approved label.
Summary: Across both study types, clinically relevant and statistically significant reductions in mean MS spasticity 0–10 NRS scores were measured soon after treatment start and were maintained in the mid to long term in treatment responders. Initial responder rates (≥ 20% NRS improvement from baseline at week 4) ranged from 47.6% to 81.4%, tending lower in the randomized clinical trials setting. Clinically relevant responder rates (≥ 30% NRS improvement from baseline at week 12) were similar between study types (range 3041%) except for one outlier (74% in an observational study). Two open studies reported treatment continuation for ≥ 18 months in approximately half of patients who initiated treatment. In most longer-term studies, symptomatic improvement in MS spasticity was maintained at mean daily dosages of about 67 sprays/day. Safety was consistent with the known profile of nabiximols.
Key messages: Experimental and observational studies of nabiximols oromucosal spray recorded similar findings. About half to two-thirds of MS patients who begin treatment will perceive initial symptomatic relief of spasticity within the 4-week trial period. About 40% of patients who initiate treatment will reach the ≥ 30% NRS improvement threshold at 3 months, comprising the majority of patients who continue long-term treatment. A trial of therapy with nabiximols is useful to identify patients most likely to gain longer-term improvement in spasticity symptoms and discontinue those with insufficient benefit.
S. Karger AG, Basel
Article / Publication Details
Copyright / Drug Dosage / Disclaimer
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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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