Management of relapsing/remitting multiple sclerosis with copolymer 1 (Copaxone)

Copolymer I (Copazone) was evaluated in a multicenter, placebo-controlled, double-blind trial at 11 universities. Two hundred and fifty-one relapsing-remitting ambulatory MS patients were randomized to receive 20 mg of copolymer I or placebo by daily subcutaneous injection for approximately 30 months. At conclusion, the copolymer I group had 32% fewer relapses (P = 0.002) and significantly more were relapse-free (P = 0.035). Significantly, more patients were receiving copolymer I had improved during the study, while more patients on placebo showed neurological decline (P = 0.001). There were few side effects and no drug related laboratory abnormalities. Copolymer I is being considered by North American and European regulatory agencies for approval as commercially available agent for the control of multiple sclerosis.