Nabiximols oromucosal spray, an experimental treatment for multiple sclerosis (MS) spasticity, failed to meet its primary endpoint in the RELEASE MSS1 (NCT04657666) phase 3 clinical trial, according to a press release from its developer, Jazz Pharmaceuticals.

During the trial, patients did not meet the primary endpoint of a significant change in Lower Limb Muscle Tone-6, as measured by the Modified Ashworth Scale, between baseline and day 21 compared to placebo.

A total of 68 patients were enrolled in the double-blind study and randomized 1:1 to receive either nabiximols oromucosal spray or a placebo for a period of time. After the first period, patients swapped to the other study drug.

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“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. We look forward to additional data from two other ongoing trials that have the potential to support a U.S. FDA New Drug Application submission,” said Rob Iannone, MD, MSCE, executive vice president and global head of research and development at Jazz Pharmaceuticals.

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Nabiximols oromucosal spray is still being investigated as a therapy for spasticity in patients with MS in 2 other phase 3 trials including RELEASE MSS3 (NCT04203498) and RELEASE MSS5 (NCT04984278).

Nabiximols oromucosal spray is a botanical mixture of components extracted from the cannabis sativa plant including delta-9-tetrahydrocannabinol (THC), cannabidiol, and other cannabinoid and noncannabinoid components, according to the company. The spray is indicated as a treatment for moderate to severe spasticity in patients with MS who have not responded to other antispasticity medications.

No cannabis-derived medications that contain THC have been approved by the US Food and Drug Administration, currently, and Epidiolex® is the only approved therapy derived from cannabis.


Jazz Pharmaceuticals announces top-line results from the phase 3 trial evaluating nabiximols oromucosal spray in adult participants with multiple sclerosis spasticity. News release. Jazz Pharmaceuticals; June 28, 2022.