Jazz Pharmaceuticals announced that a phase 3 multiple sclerosis trial of its cannabis-derived spray — already approved in 29 countries — failed to meet study endpoints, dashing hopes of expanding the drug's approval to the U.S.
Top-line results from the RELEASE MSS1 trial evaluating nabiximols oromucosal spray (branded Sativex outside the U.S.) on clinical measures of spasticity in individuals with MS revealed that the 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.
The spray is a complex botanical mixture formulated from extracts of the cannabis sativa plant and contains the cannabinoids delta-9-THC and cannabidiol (CBD), as well as other cannabinoid and non-cannabinoid components. Sativex was first approved in the U.K. in 2010 and since 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.
Ireland-based Jazz jumped into the CBD market full force last Feb., plunking down $7.2 billion to buy GW Pharmaceuticals — the first company to win an FDA approval for a cannabis-based treatment. GW won approval for Epidiolex in 2018, a plant-derived cannabinoid treatment for two rare forms of early childhood epilepsy. At the time of the deal, Sativex was in late-stage trials for multiple sclerosis and spinal cord injury.
According to Jazz, the RELEASE MSS1 trial was the first, and smallest, of three clinical trials in the current program. Data from these trials will continue to be evaluated as it becomes available, to support the overall program in the U.S, says the drugmaker.