A Novel ω-3 Acid Ethyl Ester Formulation Incorporating Advanced Lipid Technologies (ALT) Improves Docosahexaenoic Acid and Eicosapentaenoic Acid Bioavailability Compared with Lovaza.

PURPOSE

The US Food and Drug Administration has approved several highly purified ω-3 fatty acid prescription drugs for the treatment of severe hypertriglyceridemia. These differ in the amounts and forms of docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). This study compared the bioavailability of SC401 (1530 mg EPA-ethyl esters [EEs] and DHA-EEs plus Advanced Lipid Technologies [ALT], a proprietary lipid-delivery platform to improve absorption), with. Lovaza (3600 mg ω-3, primarily EPA-EEs and DHA-EEs) under low-fat feeding conditions.

METHODS

This was a Phase I, randomized, open-label, single-dose, 2-way crossover study in healthy participants housed from day -3 to day 2 in each treatment period. Blood samples for pharmacokinetic measurements were collected before and after dosing, and safety profile and tolerability were assessed.

FINDINGS

In unadjusted analyses, SC401 had 5% lower C and approximately the same AUC of EPA + DHA total lipids compared with Lovaza. When adjusted for baseline, SC401 had 6% higher C and 18% higher AUC for EPA + DHA total lipids, and dose- and baseline-adjusted analyses found that SC401 had ~149% higher C and 178% higher AUC than Lovaza for EPA + DHA total lipids. The T was also substantially longer with Lovaza (10 hours) than with SC401 (~6 hours).

IMPLICATIONS

These results indicate that SC401, an ω-3 acid EE formulation containing ALT achieved high bioavailability of EPA and DHA, at a lower dose (1530 mg) than Lovaza (3600 mg), under low-fat feeding conditions.