Shots:
The P-III (RELEASE MSS1) trial evaluated nabiximols oromucosal spray in a ratio (1:1) in 68 adult patients with MS spasticity for 3wk.
The trial failed to meet the 1EPs of change in LLMT-6 b/w baseline & Day 21 as measured by MAS & 2EPs include a change in LLMT-4 as defined by the MAS. The safety profile was consistent with prior reported AEs with no new safety signals to nabiximols oromucosal spray
Nabiximols oromucosal spray also known as Sativex (Ex-US and 1st approved in the UK in 2010) has been approved in 29 countries for mod. to sev. spasticity due to MS who have not responded adequately to other anti-spasticity medication based on prior completed clinical trials
Ref: PRNewswire | Image: Jazz
