Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has announced positive results from a study of a new formulation of its multiple sclerosis treatment, Copaxone, which contains the same currently approved dose in half the injection volume.
The SONG study (Study of New Glatiramer Acetate Formulation) explored the safety and tolerability of a 20mg/0.5mL injection of Copaxone compared with the current formulation of 20 mg/1.0mL. The findings were presented at the 24th Annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in San Antonio, Texas.
The SONG study enrolled 148 relapsing-remitting multiple sclerosis patients at 21 sites in the US. Data demonstrated that both the 1.0mL and 0.5mL products were safe and well tolerated. Patients receiving the lower-volume injection reported significantly less pain immediately following and five minutes after administration. Although the presence of injection site reactions (swelling, redness, itching, or lumps) was not high for either group, patients reported fewer and less severe reactions within five minutes and 24 hours post-administration with the newer product.
Multiple Sclerosis Clinic of Colorado director Dr. Ronald Murray said, “We are encouraged by these data as they suggest that a 0.5mL dose of glatiramer acetate may enhance patients’ experience with the most frequently prescribed multiple sclerosis therapy."
Published by Globes [online], Israel business news - www.globes-online.com - on June 6, 2010
© Copyright of Globes Publisher Itonut (1983) Ltd. 2010