Vazalore 325 mg — The First-Ever Liquid-Filled Aspirin Capsule Approved by the FDA

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Company Overview

We are a late-stage specialty pharmaceutical company initially focused on developing our clinically validated and patent-protected PLxGuard delivery system to provide more effective and safer aspirin products. Our PLxGuard delivery system works by releasing active pharmaceutical ingredients into the duodenum, the first part of the small intestine immediately below the stomach, rather than in the stomach itself. We believe this improves the absorption of many drugs currently on the market or in development, and reduces acute gastrointestinal (GI) side effects—including erosions, ulcers, and bleeding — associated with aspirin and ibuprofen, and potentially other drugs.

Our U.S. Food and Drug Administration (FDA) approved lead product, Vazalore 325 mg, is a novel formulation of aspirin that uses the PLxGuard delivery system to significantly reduce acute GI side effects while providing antiplatelet effectiveness for cardiovascular disease prevention as compared with the current standard of care, enteric coated aspirin. A companion 81 mg dose of the same novel formulation — Vazalore 81 mg —is in late-stage development and will be the subject of a supplemental New Drug Application (sNDA) leveraging the already approved status of Vazalore 325 mg.

Our commercialization strategy will target both the over-the-counter (OTC) and prescription markets, taking advantage of the existing OTC distribution channels for aspirin while leveraging the FDA approval of Vazalore 325 mg and expected approval for Vazalore 81 mg for OTC and prescription use when recommended by physicians for cardiovascular disease treatment and prevention. Given our clinical demonstration of better antiplatelet efficacy (as compared with enteric coated aspirin) and better acute GI safety, we intend to use a physician-directed sales force to inform physicians—and, by extension, consumers—about our product’s clinical results in an effort to command both greater market share and a higher price for our new aspirin product.

Our product pipeline also includes other oral nonsteroidal anti-inflammatory drugs (NSAIDs) using the PLxGuard delivery system that may be developed, including a clinical-stage, GI-safer ibuprofen — PL1200 Ibuprofen 200 mg — for pain and inflammation.

Scientific Advisory Board

  • Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC

    Executive Director of Interventional CV Programs
    Brigham and Women’s Hospital Heart & Vascular Center
    Professor of Medicine,
    Harvard Medical School
    Boston, MA, USA

  • P. Gabriel Steg, MD,

    Director of the Coronary Care Unit, Hôpital Bichat-Claude
    Professor of Cardiology, Univ. Paris VII - Denis Diderot
    Professor at the National Heart and Lung Institute, Imperial College, London, UK
    Paris, FRANCE

  • Dominick J. Angiolillo, MD, PhD, FACC, FESC, FSCAI

    Program Director, Interventional Cardiology Fellowship
    Professor of Medicine, Director, Cardiovascular Research
    University of Florida College of Medicine-Jacksonville
    Jacksonville, FL, USA

  • Roxana Mehran, MD, FACC

    Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Mount Sinai School of Medicine

  • Byron Cryer, MD

    Associate Dean for Faculty Diversity and Development
    Professor of Medicine, UT Southwestern Medical School
    Dallas, TX, USA

  • James M. Scheiman, MD

    James M. Scheiman, MD

    David Stone Professor of Internal Medicine
    Chief, Division of Gastroenterology and Hepatology
    Digestive Health Service Line Medical Director, University of Virginia Health System
    University of Virginia
    Charlottesville, VA, USA

  • Mark J Alberts, MD

    Ayer Neuroscience Institute
    Hartford Healthcare Chief of Neurology
    Hartford Hospital, Professor of Neurology UCONN School of Medicine

  • Jayne Prats, PhD

    Elysis Medical Scientific Solutions
    Boston, MA, USA

  • Efthymios Deliargyris, MD, FACC, FESC, FSCAI

    Chief Medical Officer
    CytoSorbents Corporation
    Monmouth Junction, NJ, USA

  • Carey Kimmelstiel, MD, FACC, FACP, FSCAI

    Director, Catheterization Laboratory and Interventional Cardiology, Tufts Medical Center
    Professor of Medicine, Tufts University School of Medicine
    Boston, MA, USA

  • Todd K. Rosengart, MD

    Professor and Chairman, DeBakey-Bard Chair of Surgery
    Michael E. DeBakey Department of Surgery
    Baylor College of Medicine
    Houston, TX, USA