Evaluation of the tolerability and efficacy of Sativex in multiple sclerosis

Abstract

Refractory spasticity, central neuropathic pain and bladder dysfunction are common clinical problems in patients with multiple sclerosis (MS). None of the currently available oral medications has proven to be reliably effective and can be limited by toxicity. Cannabinoids have shown therapeutic effects on those MS-associated symptoms. Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) Sativex (nabiximols) is an oromucosal spray formulation that contains THC and CBD in an approximate 1:1 ratio and is described as an endocannabinoid system modulator. The efficacy of THC/CBD on MS-associated spasticity, pain and bladder dysfunction has been studied in clinical trials as well as in clinical practice studies. Adverse effects are usually mild or moderate and the low rate of drug discontinuation provides good evidence of long-term tolerability. This article focuses on the pharmacological properties, clinical efficacy and tolerability of THC/CBD in MS patients.

Keywords::

• cannabinoids
• central neuropathic pain
• multiple sclerosis
• nabiximols
• Sativex
• spasticity

Financial & competing interests disclosure

A Garcia-Merino has received honoraria for lecturing, consulting or travel expenses from Bayer, Biogen-Idec, Merck, Teva, Novartis, Roche, Almirall and Genzyme, and research grants from Merck and Novartis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Spasticity, central pain and bladder dysfunction are significant problems for multiple sclerosis (MS) patients and the conventional options usually do not provide adequate control.

• Sativex is a new cannabinoid medicine recently licensed for the treatment of muscle spasticity associated with MS.

• Most of the trials have shown to improve subjective spasticity in MS patients with inadequate response to other antispasticity medications.

• Sativex has improved central pain and some aspects of bladder dysfunction in MS.

• Safety and tolerability are generally good; tolerance induction and dose increasing have not been reported.

• New observational data and clinical experience reinforce the efficacy and safety observed in Phase III clinical trials.