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news.Omthera Pharmaceuticals has reached an agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of its planned Phase III registration clinical trial of Epanova, for the treatment of patients with very high triglycerides.
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Epanova is an Omega 3 fatty acid containing a new formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Omthera Pharma said that the multi-center, placebo-controlled, randomised, 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 500mg/dl.
Omthera Pharma’s Epanova 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.
Omthera Pharma president and CEO Jerry Wisler said that the SPA marks an important milestone for Omthera, providing a clear regulatory pathway to approval for Epanova in this patient population.
In addition to the EVOLVE study, Omthera has initiated a pharmacokinetic trial for Epanova, known as ECLIPSE (Epanova Compared to Lovaza In a Pharmacokinetic, Single-dose Evaluation), intended to demonstrate bioavailability advantages over currently available prescription Omega 3 products.
Principal investigator for the EVOLVE study John Kastelein said that Epanova has the potential to be a therapy to help patients control their triglyceride levels.