On June 14, 2012, Teva Pharmaceuticals Industries Ltd. announced positive results from a Phase III trial assessing the safety and efficacy of 40 mg/1 ml Copaxone (glatiramer acetate) injection. The study found that Copaxone injection administered subcutaneously three times per week significantly reduced disease activity in relapsing-remitting multiple sclerosis (RRMS) patients compared to placebo.
The one-year study consisted of over 1,400 patients. Patients treated with Copaxone exhibited a significantly reduced annualized relapse rate by 34.4% compared to patients treated with placebo. The 40 mg / 1 ml injection assessed in the study is higher than the currently marketed 20 mg/1 ml daily Copaxone.
Serge Stankovic, Senior Vice President of Clinical Research, Global Branded R&D,?Teva Pharmaceutical Industries Ltd., said, ?We are pleased with the results of this study that show the potential of 40 mg/1 ml glatiramer acetate to offer patients an effective and safe treatment option with COPAXONE? using a more convenient dosing regimen.?
Teva?s press release stated that analyses of the study are ongoing and results will be presented in the near future. The most commonly reported adverse events associated with Copaxone treatment in this study were injection site reactions, headaches, and nasopharyngitis.
Copaxone is indicated for the reduction of the frequency of relapses in relapsing-remitting MS, including patients who have experienced a first clinical episode and have MRI features consistent with MS. Copaxone was FDA approved on December 20, 1996 and is marketed by Teva Pharmaceuticals.
Using data from AERS, from 01/01/2004 to 3/31/2012, aggregated and standardized by the AdverseEvent RxFilter process, we identified 5,648 patients who experienced a serious adverse event where Copaxone was identified as a suspect drug causing the event and 3,986 patients who experienced a serious adverse event where Copaxone was identified as the primary suspect. The most commonly reported side effects were multiple sclerosis relapse, dyspnea (shortness of breath), and urticarial (hives). We identified 1,315 hospitalizations and 185 deaths where Copaxone was identified as the primary suspect.