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.

A Sativex®‐like combination of phytocannabinoids as a disease‐modifying therapy in a viral model of multiple sclerosis

“…There is a wealth of data from clinical trials that support the efficacy and safety of Sativex in patients with MS-related spasticity (Collin et al, 2007;Wade et al, 2010;Sastre-Garriga et al, 2011;García-Merino, 2013). However, to date, there are no clinical studies evaluating Sativex as a disease-modifying agent of progressive MS.…”

Evidence for the efficacy and effectiveness of THC-CBD oromucosal spray in symptom management of patients with spasticity due to multiple sclerosis

“…ECBs activate presynaptic G-protein-coupled CB 1 receptors, thus inhibiting presynaptic calcium influx and neurotransmitter release. outcomes have been summarized and discussed in detail in other publications [Sastre-Garriga et al 2011;Leussink et al 2011;Garcia-Merino et al 2014;Syed et al 2014] and are only briefly discussed here. Table 1 summarizes the main characteristics and key efficacy results.…”

The Endocannabinoid System as a Potential Therapeutic Target for Pain Modulation

“…In addition to its wide therapeutic spectrum, cannabidiol is proposed to reverse some of the central side effects of THC (21)(22)(23). Nabiximols (Sativex  ), a herbal cannabis extract containing THC and cannabidiol at a 1:1 ratio in an oromucosal spray, has been approved for the treatment of neuropathic pain and spasticity associated with multiple sclerosis and intractable cancer pain (24).…”