THC and CBD oromucosal spray (Sativex^®) in the management of spasticity associated with multiple sclerosis

Abstract

People with multiple sclerosis may present with a wide range of disease symptoms during the evolution of the disease; among these, spasticity can have a marked impact on their well-being and quality of life. Symptom control, including spasticity, remains a key management strategy to improve the patient’s well-being and functional status. However, available drug therapies for spasticity sometimes have limited benefit and they are often associated with poor tolerability. Sativex is a 1:1 mix of 9-delta-tetrahydrocannabinol and cannabidiol extracted from cloned Cannabis sativa chemovars, which is available as an oromucosal spray. Clinical experience with Sativex in patients with multiple sclerosis is accumulating steadily. Results from randomized, controlled trials have reported a reduction in the severity of symptoms associated with spasticity, leading to a better ability to perform daily activities and an improved perception of patients and their carers regarding functional status when Sativex was added to the current treatment regimen. Adverse events such as dizziness, diarrhea, fatigue, nausea, headache and somnolence occur quite frequently with Sativex, but they are generally of mild-to-moderate intensity and their incidence can be markedly reduced by gradual ‘uptitration’. In summary, initial well-controlled studies with Sativex oromucosal spray administered as an add-on to usual therapy have produced promising results and highlight encouraging avenues for future research.

Keywords::

• cannabidiol
• delta-9-tetrahydrocannabinol
• multiple sclerosis
• nabiximols
• Sativex
• spasticity

Financial & competing interests disclosure

Almirall and Bayer are the European/UK distributors of Sativex and this review was sponsored by Laboratorios Almirall, S.A., Spain.

Carlos Vila is an employee of Laboratorios Almirall, S.A., Spain. Stephen Clissold is an editorial consultant at ContentEdNet.

Jaume Sastre-Garriga has served as a consultant or member of a company advisory board for Novartis, Almirall, Bayer Schering Pharma, Biogen, Merck-Serono and TEVA, and has acted as a speaker for Almirall, Bayer Schering Pharma, Biogen, Merck-Serono, Novartis and Sanofi-Aventis.

Xavier Montalban has served as a consultant or member of a company advisory board for Novartis, Almirall, Bayer Schering Pharma, Biogen, Merck-Serono, Sanofi-Aventis and TEVA, and has acted as a speaker for Almirall, Bayer Schering Pharma, Biogen, Merck-Serono Novartis and Sanofi-Aventis. 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.

Writing assistance was utilized in the production of this manuscript. Laboratorios Almirall, S.A. funded this assistance.