An Irish biopharmaceutical company has announced top-line results from its Phase 3 trial on a cannabinoid-based multiple sclerosis (MS) treatment.
According to Jazz, the 21-day trial did not meed the endpoint of change in Lower Limb Muscle Tone-6 (LLMT-) using the Modified Ashworth Scale (MAS).
Jazz says the RELEASE MSS1’s safety profile was consistent with previously-reported adverse events, with no new safety signals that it could attribute to the spray.
Jazz says its spray also includes additional cannabinoid and non-cannabinoid ingredients.
Sativex currently has approval in 29 countries as a treatment for moderate to severe MS spasticity in adults who have responded poorly to other anti-spasticity medications.
“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,” says Jazz Executive VP Rob Iannone, MD. “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.”
Jazz says MSS1 was the first and smallest of the current program’s three clinical trials in which Jazz evaluated the Sativex spray’s efficacy in 68 patients with MS spasticity.
To support the overall registrational program in the United States, Jazz says it will continue to evaluate trial data as it becomes available.
Jazz says there are two additional ongoing Phase 3 trials to complement and inform a comprehensive development plan.
One of the Phase 3 trials, RELEASE MSS3, is a 12-week, multicenter, double-blind, placebo-controlled trial to evaluate the Sativex spray’s efficacy in improving MS-associated muscle spasms.
Jazz estimates enrollment to be approximately 446 participants.
The other Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled, 2-treatment, 2-period, crossover trial to study how multiple Sativex doses compare to placebos on a clinical measure of velocity-dependent muscle tone in lower limbs of MS patients.
Jazz estimates that approximately 190 participants will enroll in the three-week trial.
Jazz says it will submit the RELEASE MSS1 trial data for presentation at a future medical meeting.