Nabiximols oromucosal spray improves spasticity in people with multiple sclerosis.

Clinician- and patient-rated measures showed reduced spasticity scores with nabiximols.

Nabiximols improved spasticity numeric rating scale scores and daily spasm counts.

Clinician-rated Modified Ashworth Scale scores were improved with nabiximols.

Nabiximols has a larger effect on muscle groups more affected by spasticity.

To provide a comprehensive assessment of the treatment effects of nabiximols oromucosal spray on multiple sclerosis spasticity in two clinical trials, GWSP0604 and SAVANT.

Both studies enriched for responders before randomization, defined by a ≥20% improvement in Spasticity 0-10 numeric rating scale (NRS) score. Additionally, SAVANT used randomized re-titration following washout. Spasticity NRS outcomes, spasm count, and modified Ashworth scale (MAS) scores were analyzed.

Mean change from baseline in average daily Spasticity NRS scores was significantly larger for nabiximols than placebo at all postbaseline timepoints, ranging from -0.36 to -0.89 in GWSP0604 and -0.52 to -1.96 in SAVANT. Percent reduction in geometric mean change from baseline in average daily spasm count for nabiximols ranged from 19–35% versus placebo. A treatment difference favoring nabiximols was observed in overall MAS scores during the randomized part of each study. Treatment effect was larger for combinations of lower limb muscle groups (ranging between -0.16 and -0.37).

Nabiximols leads to improvement in spasticity that was sustained over the 12-week treatment period as measured by average daily Spasticity NRS scores, daily spasm counts, and MAS scores for combinations of muscle groups, especially the combination of the 6 key muscle groups in the lower limbs in NRS responders to nabiximols treatment.

Multiple sclerosis

Spasticity

Sativex

THC

CBD

Nabiximols

analysis of covariance

clinically important difference

interactive voice response system

lower limb muscle tone

Modified Ashworth Scale

minimum clinically important difference

mixed model for repeated measures

North American Research Committee on Multiple Sclerosis

delta-9-tetrahydrocannibinol

© 2023 The Authors. Published by Elsevier B.V.