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.

Read more about experimental therapies for MS

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.

Reference

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.

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