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.