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Alexza Pharmaceuticals Inc. Message Board

stevensboy2001 1 post  |  Last Activity: Feb 25, 2014 9:14 AM Member since: May 20, 2002
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  • stevensboy2001 by stevensboy2001 Feb 25, 2014 9:14 AM Flag

    December 17, 2012Amarin Announces Completion of Dosing in a Fixed-Dose Combination Study With Vascepa(R) and a Leading Statin

    BEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 17, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has completed dosing and pharmacokinetic sampling in a study to test a fixed-dose combination of Vascepa® (icosapent ethyl) capsules and a leading statin. The clinical name for this combination product is AMR102. Prior to commencement of the study, Amarin opened an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration which became effective after the standard 30-day review.

    The purpose of this AMR102 study is to determine the bioavailability of the EPA (eicosapentaenoic acid) and statin components when taken as a fixed-dose combination product, relative to the individual reference agents taken concomitantly. Statin bioavailability from both the fixed-dose and concomitant regimens will also be compared with that from the reference statin taken alone in healthy subjects. Additionally, pharmacokinetic data from this study will be examined to explore relationships between in vitro dissolution data and in vivo pharmacokinetic data. The study is designed as a randomized, open-label, multiple dose, parallel-group study in 48 healthy subjects conducted at a single site in the United States.

    "This study is aimed at expanding the potential commercial application of Vascepa by leveraging the clinical successes of the MARINE and ANCHOR trials, namely effective triglyceride lowering without increasing LDL-C," stated Joseph Zakrzewski, Amarin's Chairman and Chief Executive Officer. "Amarin's goal is to identify ways for patients to simplify their lipid management by developing a single therapy that offers the powerful triglyceride lowering effects of Vascepa combined with one of the most prescribed statin products."

    Amarin looks forward to analyzing the results from this study and expects to communicate such results in the first half of 2013.

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