Jazz Pharmaceuticals made its cannabis drug ambitions clear last year with a $7.2 billion acquisition of GW Pharmaceuticals and again in March when it started building a plant in the U.K. designed specifically for cannabis-based medicines.
But three months later, Jazz has revealed a setback, saying that its nabiximols oromucosal spray has flunked a phase 3 trial, coming up short in helping multiple sclerosis patients with spasticity.
Over a 21-day span, the spray—known as Sativex and on the market in Europe for 12 years—failed to improve lower-limb muscle tone 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 doing 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 U.S. FDA new drug application submission,” Rob Iannone, M.D., EVP, global head of research and development at Jazz, said in a release.
Jazz reported that sales of its other cannabis-derived medicine, epilepsy treatment Epidiolex, reached $464 million last year. Sativex’s revenue came in at $13 million in 2021.