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

Abstract 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 max and approximately the same AUC 0–last of EPA + DHA total lipids compared with Lovaza. When adjusted for baseline, SC401 had ~6% higher C max and 18% higher AUC 0–last for EPA + DHA total lipids, and dose- and baseline-adjusted analyses found that SC401 had ~149% higher C max and 178% higher AUC 0–last than Lovaza for EPA + DHA total lipids. The T max 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.