TEVA BEGINS STUDY OF MULTIPLE SCLEROSIS DRUG
Teva Pharmaceutical has announced the initiation of a large Phase III study designed to confirm the positive results from the Phase II study, which compared a new higher dose of 40 mg per day dose of glatiramer acetate (GA) to the currently approved Copaxone 20 mg for multiple sclerosis. The study, called FORTE, is beginning the enrollment of approximately 1,000 patients in 160 centers across North America, Europe, Argentina and Israel.
The study will be a 12-month, randomized, parallel-group, double-blind trial. Patients will be equally randomized into one of two groups: 40 mg GA once daily or Copaxone 20 mg once daily. The study objectives include comparing the efficacy and safety of daily subcutaneous injections of GA to that of Copaxone in relapsing-remitting multiple sclerosis (MS) RRMS patients. Patients completing the 12-month phase will continue in the study for an additional 12-month, open-label phase in which all subjects will receive 40 mg per day of GA.