A 9-month, randomised, double-blind, parallel-group phase II study of 90 patients comparing a 40 mg dose of Copaxone given daily to the currently approved Copaxone 20 mg dose showed a 38 per cent greater reduction in inflammatory disease activity as measured by magnetic resonance images (MRI) of the brain.
In addition, patients taking Copaxone 40 mg experienced a reduced mean on-trial relapse rate of 77 per cent when compared to annual relapse rate prior to entry, as compared to 62 per cent with Copaxone 20 mg. The results of this study, entitled "Randomised, double-blind, dose comparison of glatiramer acetate in relapsing-remitting MS," were published in a recent issue of Neurology.
"Copaxone is an established RRMS therapy with more than 12 years of clinical research and experience supporting its efficacy and safety. The recently published data demonstrated that a 40 mg dose was well tolerated, with a safety profile similar to the currently available 20 mg dose," said Jeffrey A. Cohen, director of the Experimental Therapeutics Programme at Cleveland Clinic's Mellen Centre for MS Treatment and Research and Coordinating Principal Investigator of the study. "In addition, the results suggested that a 40 mg dose of Copaxone may provide better control of disease activity, and justify additional research on the therapeutic effect of higher dosages of this drug."
Based upon the results of this study, a large-scale Phase III study designed to confirm the higher efficacy of Copaxone with the increased dose has been initiated.
In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. Copaxoneis a registered trademark of Teva Pharmaceutical Industries Ltd. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.