The study compared a 40mg dose of Copaxone given daily to the currently approved Copaxone 20mg dose. It was also designed to test the safety and tolerability of the 40mg dose over a period of 9 months. The higher dose showed a 38% greater reduction in inflammatory disease activity as measured by magnetic resonance images (MRI) of the brain.
In addition, patients taking Copaxone 40mg experienced a reduced mean on-trial relapse rate of 77% when compared to annual relapse rate prior to entry, as compared to 62% with Copaxone 20mg.
“The results suggested that a 40mg dose of Copaxone may provide better control of disease activity, and justify additional research on the therapeutic effect of higher dosages of this drug,” said Jeffrey Cohen, director of the Experimental Therapeutics Program at Cleveland Clinic’s Mellen Center for MS Treatment.
Based upon the results of this study, a phase III study designed to confirm the higher efficacy of Copaxone with the increased dose has been initiated.