Epanova is an ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
The double-blind, multi-center, randomized, placebo-controlled is a 12 week trial which is designed to assess the safety and efficacy of three doses of Epanova in patients with fasting triglyceride (TG) levels of greater than or equal to 500 mg/dL.
The primary endpoint of the trial is the percentage change in triglyceride level from baseline to week 12.
The secondary endpoint is the reduction to non-HDL cholesterol.
Omthera Pharmaceuticals CEO and co-Founder Jerry Wisler said they have been very encouraged by the positive clinical profile of Epanova to date, and completion of enrollment in this pivotal study brings the Omega-3 therapy to patients suffering from very high triglycerides.
"We very much look forward to seeing the data-set in April 2012," Wisler said.