EXTENDED USE OF GLATIRAMER ACETATE (COPAXONE) IS WELL TOLERATED AND MAINTAINS ITS CLINICAL EFFECT ON MULTIPLE-SCLEROSIS RELAPSE RATE AND DEGREE OF DISABILITY

When 251 relapsing-remitting patients with multiple sclerosis were ran domized to receive daily subcutaneous injections of glatiramer acetate , previously called copolymer 1 (Copaxone; n = 125) or placebo (n = 12 6) for 24 months, there were no laboratory abnormalities associated wi th glatiramer acetate treatment and it was well tolerated with few sid e effects, Patients receiving glatiramer acetate had significantly few er relapses and were more likely to be neurologically improved, wherea s those receiving placebo were more likely to worsen. This study was e xtended for 1 to 11 months (mean of 5.2 months for the glatiramer acet ate group and 5.9 months for the placebo group). The blinding and stud y conditions used during the core 24-month study were unchanged throug hout the extension. The results of this extension study confirm the ex cellent tolerance and safety profile of glatiramer acetate for injecti on. The clinical benefit of glatiramer acetate for both the relapse ra te and for neurologic disability was sustained at the end of the exten sion trial.