Jazz Pharmaceuticals nabiximols oromucosal spray did not meet the primary endpoint in a phase 3 trial, failing in its aim of improving Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21, as measured by the Modified Ashworth Scale (MAS).
The spray is formulated from extracts of the cannabis sativa plant and contains tetrahydrocannabinol (THC) and cannabidiol (CBD). It has been approved in 29 countries for adults with MS spasticity who have not responded adequately to other anti-spasticity treatments.
Jazz said it will continue to evaluate the spray for use in MS patients.
With 68 participants, the Release MSS1 trial was the first and smallest of three studies Jazz is conducting with the spray in MS. Release MSS3 is examining the improvement of muscle spasms in 446 MS patients over a 12-week period. Release MSS5 is investigating velocity-dependent lower-limb muscle tone over a 21-day period in 190 MS patients.
We look forward to additional data from two other ongoing trials that have the potential to support a US FDA new drug application submission
Rob Iannone, M.D., EVP, global head of research and development at Jazz Pharmaceuticals
