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Friday

 

New Formulation of Copaxone:Teva Announces Positive Study Results


(Posted By: Josi Creek)


Significantly less pain and fewer injection site reactions were reported by patients receiving the new lower volume injection


Teva Pharmaceutical Industries Ltd. today announced positive results from a study assessing a new lower-volume injection of Copaxone(R) (glatiramer acetate) containing the 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(R) versus the current formulation of 20 mg/1.0mL.
These findings were presented at the 24th Annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in San Antonio, Texas.
"Copaxone(R) has proven long-term efficacy, safety and tolerability with more than one million patient years of treatment," said Dr. Ronald Murray, FAAN, a lead study investigator and Director of the MS Clinic of Colorado. "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 MS therapy."
The SONG study enrolled 148 relapsing-remitting MS patients (RRMS) at 21 sites in the United States. 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 (p<0.0001). Although the presence of injection site reactions (swelling, redness, itching, lumps) was not high for either group, patients reported fewer and less severe reactions within five minutes (p<0.0001) and 24 hours (p<0.0001) post-administration with the 20mg/0.5mL product. No serious adverse events were reported in the study.
"Copaxone(R) is the global market leading RRMS treatment, and Teva is continuously pursuing research focused on further enhancing the patient treatment experience with the product," said Moshe Manor, Teva's Group Vice President, Global Branded Products. "Our investment in research has already translated to increased benefits for Copaxone(R) patients, including an expanded indication to treat early-stage MS-like symptoms in patients at risk of progression to an MS diagnosis, as well as device improvements such as a thinner needle to reduce injection discomfort and an auto inject device to better facilitate treatment delivery."

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