Effect of nabiximols oromucosal spray (Sativex®) on symptoms associated with multiple sclerosis-related spasticity: a case series

Drugs Context. 2024 Feb 14:13:2023-10-1. doi: 10.7573/dic.2023-10-1. eCollection 2024.

Abstract

Spasticity and its related symptoms of spasms, pain, sleep disturbance and bladder dysfunction are common in persons with multiple sclerosis (MS) and may be interconnected through a common pathophysiology and/or may trigger and worsen each other. Tetrahydrocannabinol-cannabidiol (nabiximols) oromucosal spray (Sativex) is an add-on treatment for adults with moderate-to-severe MS spasticity who fail to respond adequately to conventional oral medications. There is evidence that nabiximols can ameliorate spasticity-associated symptoms irrespective of its effect on spasticity. This case series describes 12 adults with MS spasticity who were evaluated for symptom evolution before and during adjunctive nabiximols treatment. Nabiximols reduced spasticity severity in 11 patients, of whom 8 had a clinically important ≥30% improvement in 0-10 Numeric Rating Scale scores during treatment. In 7 patients who reported spasms, severity was reduced or spasms were absent/unnoticeable during nabiximols treatment. Walking distance was improved in 8 patients. Pain severity was reduced in 11 patients, and sleep disorder was completely resolved in 3 patients and improved in 8. Bladder dysfunction was improved in 6 of 7 patients with baseline symptoms. Two patients arguably should have discontinued nabiximols sooner: one had a limited response and experienced adverse effects throughout 6 months of treatment; the other was a non-responder who suffered a fall due to dizziness after 7 weeks of use. Overall, this case series shows, at an individual patient level, that the benefits of nabiximols extend beyond spasticity to include spasticity-related symptoms.

Keywords: Sativex; adjunctive therapy; case series; multiple sclerosis spasticity; nabiximols oromucosal spray.