High-dose Copaxone effective in RRMS trial

Israeli drugmaker Teva Pharmaceutical says that data from a Phase II trial of its multiple sclerosis drug Copaxone (glatiramer acetate injection), given at a new higher dosage, shows that the product has potential as treatment for relapsing-remitting multiple sclerosis (RRMS). The announcement was made at the 58th annual meeting of the American Academy of Neurology held, this year in San Diego.

The trial was conducted as a randomized, double-blind, parallel-group comparison of the efficacy of the drug in the treatment of RRMS, as measured by magnetic resonance imaging assessment and clinical relapse occurrence, at 20mg and 40mg dosages. In total, 90 patients with clinically defined MS who had suffered a relapse in the previous 12 months were enrolled in the trial and randomized to receive either dose for a period of nine months.

The results showed a 38% greater reduction in the mean cumulative number of gadolinium-enhancing lesions in the MRI brain scans of those subjects receiving the 40mg dose versus the 20mg cohort. Relapse rates were also lower in the group treated with 40mg of the compound than the 20mg group (0.34 versus 0.57, respectively).