title: A Novel ω-3 Acid Ethyl Ester Formulation Incorporating Advanced Lipid TechnologiesTM(ALT®) Improves Docosahexaenoic Acid and Eicosapentaenoic Acid Bioavailability Compared with Lovaza®.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  In unadjusted analyses, SC401 had 5% lower Cmaxand approximately the same AUC0-lastof EPA + DHA total lipids compared with Lovaza. When adjusted for baseline, SC401 had ~6% higher Cmaxand 18% higher AUC0-lastfor EPA + DHA total lipids, and dose- and baseline-adjusted analyses found that SC401 had ~149% higher Cmaxand 178% higher AUC0-lastthan Lovaza for EPA + DHA total lipids. The Tmaxwas also substantially longer with Lovaza (~10 hours) than with SC401 (~6 hours).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Research and Development Sancilio and Company, Inc, Riviera Beach, Florida. Electronic address: mltoledano@sancilio.com.
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Lopez-Toledano
authors.affiliation: Department of Research and Development Sancilio and Company, Inc, Riviera Beach, Florida.
authors.forename: Thorsteinn
authors.initials: T
authors.lastname: Thorsteinsson
authors.affiliation: Department of Research and Development Sancilio and Company, Inc, Riviera Beach, Florida.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Daak
authors.affiliation: Midwest Biomedical Research/Center for Metabolic and Cardiovascular Health, Glen Ellyn, Illinois.
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Maki
authors.affiliation: Department of Research and Development Sancilio and Company, Inc, Riviera Beach, Florida.
authors.forename: Colleen
authors.initials: C
authors.lastname: Johns
authors.affiliation: Department of Research and Development Sancilio and Company, Inc, Riviera Beach, Florida.
authors.forename: Adrian L
authors.initials: AL
authors.lastname: Rabinowicz
authors.affiliation: Department of Research and Development Sancilio and Company, Inc, Riviera Beach, Florida.
authors.forename: Frederick D
authors.initials: FD
authors.lastname: Sancilio
mesh_terms: D000328:Adult; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004281:Docosahexaenoic Acids / Q000008:administration & dosage* / Q000493:pharmacokinetics; D004338:Drug Combinations; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage* / Q000493:pharmacokinetics; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015228:Hypertriglyceridemia / Q000188:drug therapy; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D015525:Fatty Acids, Omega-3; D000960:Hypolipidemic Agents; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; C405603:Omacor
keywords: Advanced Lipid Technologies™; bioavailability; docosahexaenoic acid; eicosapentaenoic acid; food effect; ω-3 fatty acids