Omthera has announced it has reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the design of its planned Phase 3 registration clinical trial of Epanova (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) for the treatment of hypertriglyceridemia. This multi-center, placebo-controlled, randomized, double-blind, 12-week study will evaluate the efficacy and safety of three doses of Epanova in patients with fasting triglyceride (TG) levels of greater than or equal to 500 mg/dL. The trial is expected to enroll approximately 300 patients and will be conducted in centers throughout North America, Europe and India. The primary endpoint of the trial, known as EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs), is the percentage change in triglyceride level from baseline to week 12. Data from this study is expected in the first quarter of 2011.
Epanova is a patent protected, novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
For more information call (908) 741-4399 or visit www.omthera.com.