Jazz Pharma's Cannabidiol Mixture Spray Misses Primary Goal In Multiple Sclerosis Spasticity

  • Jazz Pharmaceuticals plc JAZZ announced topline results from the Phase 3 RELEASE MSS1 trial of nabiximols oromucosal spray on clinical measures of spasticity in multiple sclerosis. 
  • The trial did not meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21.
  • Nabiximols oromucosal spray is a complex mixture formulated from extracts of the cannabis sativa plant. It contains the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and other cannabinoid and non-cannabinoid components. 
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  • RELEASE MSS1 was the first and smallest of the three clinical trials in the current program. It evaluated the safety and efficacy of nabiximols oromucosal spray in 68 patients with multiple sclerosis spasticity.
  • The company has two additional Phase 3 trials to o complement and inform a comprehensive development plan.
  • 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.
  • Price Action: JAZZ shares closed at $156.69 on Monday.
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