Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced top-line results from the Phase 3 RELEASE MSS1 trial (NCT04657666) evaluating nabiximols oromucosal spray (JZP378, or Sativex ®, ex-U.S.) on clinical measures of spasticity in individuals with multiple sclerosis (MS). The RELEASE MSS1 trial did not meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21, as measured by the Modified Ashworth Scale (MAS).
Nabiximols oromucosal spray is a complex botanical mixture formulated from extracts of the cannabis sativa plant and contains the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), as well as other cannabinoid and non-cannabinoid components. Nabiximols oromucosal spray (known as Sativex ex-U.S. and first approved in the U.K. in 2010) has been approved in 29 countries for the treatment of adult patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication based on previously completed clinical trials.
“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, M.D., M.S.C.E., executive vice president, global head of research and development at Jazz Pharmaceuticals. “I would like to extend a heartfelt thank you to all those who supported and made this study possible, including the patients who were enrolled, their families, our investigators, staff, and all of the dedicated Jazz employees.”
RELEASE MSS1 was the first, and smallest, of the three clinical trials in the current program, and it evaluated the safety and efficacy of nabiximols oromucosal spray in 68 patients with MS spasticity. Data from these trials will continue to be evaluated as it becomes available, to support the overall registrational program in the U.S. Two additional, ongoing Phase 3 trials to complement and inform a comprehensive development plan include:
- RELEASE MSS3: A Phase 3 multicenter, double-blind, placebo-controlled trial evaluating the efficacy of nabiximols oromucosal spray, compared to placebo, when added to standard of care, for the improvement of muscle spasms associated with MS over a 12-week treatment period. Estimated enrollment is 446 participants.
- RELEASE MSS5: A Phase 3 multicenter, randomized, double-blind, placebo-controlled, 2-treatment, 2-period, crossover trial evaluating the effect of multiple doses of nabiximols oromucosal spray compared to placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 [LLMT-6]) in participants with MS over a 3-week treatment period. Estimated enrollment is 190 participants.
The safety profile in RELEASE MSS1 was consistent with previously reported adverse events, with no new safety signals attributable to nabiximols oromucosal spray observed in this population.
Data from the RELEASE MSS1 trial will be submitted for presentation at a future medical meeting.