Spasticity Improved With Cannabinoid Oral Spray

Nancy A. Melville – December 24, 2018

Nabiximols, a cannabinoid-based oral spray (Sativex, GW Pharmaceuticals) approved outside the United States for various multiple sclerosis (MS) symptoms, shows benefit in improving spasticity and pain in motor neuron disease when administered as an add-on to standard therapy, new research suggests.  

“This study is, to our knowledge, the first randomized controlled trial of safety and efficacy of a pharmacological treatment for spasticity and the first trial of nabiximols in motor neuron disease,” write the authors in their article published online December 13 in Lancet Neurology.

“Our results suggest that the study drug is well tolerated and provides first evidence of efficacy in terms of controlling spasticity in patients with motor neuron disease.”

Current treatments commonly used for spasticity in motor neuron diseases such as amyotrophic lateral sclerosis (ALS), the most common and severe of these diseases, including baclofen, dantrolene, and benzodiazepines, lack evidence of efficacy in this context and are associated with undesirable side effects including increased muscle weakness or fatigue.

Nabiximols, an oral spray combining equal parts delta-9 tetrahydrocannabinol and cannabidiol (THC-CBD), has meanwhile gained favor in the treatment of spasticity in MS in countries outside of the United States where it is licensed, suggesting potential for efficacy in spasticity in other diseases.

For the current proof-of-concept study, first author Nilo Riva, MD, of the IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy, and colleagues enrolled 60 patients with at least 3 months of spasticity symptoms associated with known or suspected ALS or primary lateral sclerosis(PLS) who were already taking an anti-spasticity regimen for at least 30 days prior to enrollment.  

Patients were randomized to add-on treatment with nabiximols at an escalated dose to a predefined level titrated over 14 days or placebo for 6 weeks.

The study reached its primary endpoint with improvement in spasticity, assessed by change in the spasticity score of the Modified Ashworth Scale (MAS), which measures intensity of muscle tone, by a mean of 0.11 (SD, 0.48) in the nabiximols group (n = 59) compared with a deterioration of a mean of 0.16 (SD, 0.47) in the placebo group (n = 30; P = .01) over the course of the study.

Greater improvements were also observed in pain scores, reported on a scale of 0 to 10, with nabiximols (-0.97 vs -0.06) and in patient-reported global impression of change (P = .001).

Although there were no significant differences in other secondary endpoints, including sleep quality, spasms, spasticity, strength, upper and lower motor neuron tests, and scores on the Amyotrophic Lateral Sclerosis Functional Rating Scale — Revised, the scores suggested some benefit, Riva told Medscape Medical News.

“Although the effects on spasms, sleep disruption, and spasticity NRS scores were not significant, the direction of change was consistently in favor of the active treatment, and the pain NRS score improved significantly in nabiximols recipients,” Riva said.

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