Topline results were announced from a phase 3 trial evaluating the efficacy and safety of nabiximols oromucosal spray (JZP378) on clinical measures of spasticity in adults with multiple sclerosis.

Nabiximols oromucosal spray is an investigational complex botanical mixture formulated from extracts of the cannabis sativa plant. The investigational treatment contains the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), along with other cannabinoid and noncannabinoid components.

The randomized, double-blind, placebo-controlled, 2-way crossover trial (RELEASE MSS1; ClinicalTrials.gov Identifier: NCT04657666) included 68 adult patients with a confirmed diagnosis of any disease subtype of multiple sclerosis for at least 12 months prior to the first visit. Study participants were randomly assigned to receive 1 of 2 treatment sequences, each composed of 2 treatment periods, with administration of multiple doses of either nabiximols oromucosal spray or placebo.

Results demonstrated that treatment with nabiximols oromucosal spray did not meet the primary endpoint of change from baseline in Lower Limb Muscle Tone-6 at day 21, as measured by the Modified Ashworth Scale. The safety profile of nabiximols oromucosal spray was consistent with previously reported adverse events, with no new safety signals.

“We remain committed to the nabiximols program and are actively assessing the RELEASE MSS1 trial results, which will be presented at a future medical meeting,” said Rob Iannone, MD, MSCE, executive vice president, global head of research and development at Jazz Pharmaceuticals. “We look forward to additional data from 2 other ongoing trials that have the potential to support a US FDA New Drug Application submission.”

The Company is currently evaluating nabiximols oromucosal spray on clinical measures of spasticity in patients with multiple sclerosis in two other phase 3 trials: RELEASE MSS3 (ClinicalTrials.gov Identifier: NCT04203498) and RELEASE MSS5 (ClinicalTrials.gov Identifier: NCT04984278).

Reference

Jazz Pharmaceuticals announces top-line results from phase 3 trial evaluating nabiximols oromucosal spray in adult participants with multiple sclerosis spasticity. News release. Jazz Pharmaceuticals plc. Accessed June 28, 2022. https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-top-line-results-from-phase-3-trial-evaluating-nabiximols-oromucosal-spray-in-adult-participants-with-multiple-sclerosis-spasticity-301576738.html