The ESPRIT trial will examine the efficacy and safety of adding Epanova to statin therapy for patients with very high triglycerides.
Epanova, an omega-3 prescription drug in trial targeting patients with very high triglycerides, has enrolled the first patient for its ESPRIT Phase III clinical trial. The announcement was made by drug’s developer, Omthera Pharmaceuticals.
The ESPRIT trial will be a six-week, randomized, double-blind, placebo-controlled, parallel group study that will examine the efficacy and safety of adding Epanova to statin therapy for patients with very high triglycerides (between 200 and 500 mg/dL). It will enroll 642 subjects across approximately 100 sites in the United States.
Epanova is a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids. Ultimately, it is aimed at patients with very high triglycerides greater than or equal to 500 mg/dL. The company says that as a free fatty acid form of EPA and DHA, as opposed to the ethyl ester form, Epanova offers superior bioavailability compared to other prescription omega-3 drugs, such as Lovaza.
Epanova is also in a Phase III trial currently being conducted, called EVOLVE, and Omthera plans to file a new drug application for Epanova.