Omega-3 Pharmaceuticals Go Head to Head

Privately held specialty pharmaceuticals firm Omthera Pharmaceuticals (Bedminster, NJ) has announced the results of tests it performed comparing its Epanova omega-3 fatty acid drug for high triglycerides to leading omega-3 drug Lovaza. The company says results show that Epanova was significantly more bioavailable than Lovaza.

The 54-subject, randomized, open-label, four-way crossover pharmacokinetics study compared the bioavailability of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in Epanova and Lovaza, with each drug taken as single 4-g dose combined with either low- or high-fat diets, over 24 hours. The company says that specifically, test results for the subjects on a low-fat diet and taking Epanova showed EPA and DHA plasma levels that were four times higher compared to those taking Lovaza. High-fat-diet subjects also showed higher EPA and DHA levels with Epanova compared with Lovaza. Omthera says that a separate analysis also showed Epanova had a 13-fold bioavailability increase over Lovaza in subjects on the low-fat diet.

The company attributes the differences to the fact that Epanova is a free-fatty-acid form of EPA and DHA, while Lovaza is an ethyl ester EPA and DHA form. It says that free fatty acids are the chemical form in which essential fatty acids are absorbed in the digestive tract. By comparison, ethyl esters require enzymatic conversion prior to absorption, and that the release of these pancreatic enzymes requires the intake of fat-containing food as a trigger.

“The ECLIPSE [Epanova Compared to Lovaza in a Pharmacokinetic Single-Dose Evaluation] study demonstrates that Lovaza is poorly absorbed in patients on a low-fat diet,” stated Michael Davidson, MD, chief medical officer and cofounder of Omthera. “We believe that this finding will have significant clinical importance because patients with sever hypertriglyceridemia should be maintained on a low-fat diet.”

Omthera says it plans to begin a Phase 3 clinical trial soon to evaluate the effects of Epanova in high-triglyceride patients.