PLx Pharma Inc. Presents Moderated Abstract and Simultaneous Publication on the Pharmacokinetic and Pharmacodynamics (PK/PD) Properties of its Novel, Liquid Aspirin Formulation at the 2019 European Society of Cardiology Congress
Abstract Title: Pharmacokinetic and pharmacodynamic assessment of a lipid-based aspirin formulation: results of a prospective, randomized, crossover study
The presentation was included in the Evolving Developments in Anti-Platelet Therapy program.
In this active-control crossover study, 16 healthy volunteers were randomized to receive single doses of 325 mg or 650 mg of either immediate release aspirin or the novel pharmaceutical lipid-aspirin complex (i.e. VAZALORE) in a sequential fashion with a two-week washout period between treatment assignments. The primary objectives of the study were to assess pharmacokinetic (i.e., plasma salicylic acid levels) and pharmacodynamic PD (i.e., serum thromboxane B2 levels) bioequivalence over a 24–hour period. The results established both PK and PD bioequivalence between the two aspirin formulations according to
“The data presented at ESC demonstrate that VAZALORE, with its novel liquid formulation, can deliver fast and reliable aspirin absorption that is bioequivalent to that seen with immediate release aspirin. These findings, together with results from previous studies showing significant reductions in the risk for gastric erosions and ulcers with VAZALORE, suggest that this novel compound may confer a superior benefit risk profile compared with currently available aspirin options,” stated Dr. Angiolillo, the lead author of the
“Aspirin remains the cornerstone of lifelong antithrombotic protection for patients with established atherosclerotic cardiovascular disease. Our data presented here complement previous studies with this lipid-based formulation of aspirin. It is encouraging that a new aspirin formulation combining reliable absorption and antiplatelet efficacy with improved GI safety may soon be available to our patients,” added
“We are thrilled to partner with our academic colleagues and generate such high-quality data that establishes the performance of our novel, liquid aspirin formulation, VAZALORE. We believe that VAZALORE has the potential to address the long-standing need for a new, better aspirin product with reliable efficacy and improved safety. We remain focused on our efforts to make VAZALORE available as soon as possible to the millions of high-risk cardiovascular patients who require reliable lifelong vascular protection,” concluded Efthymios Deliargyris, MD,
VAZALORE 325 mg is an
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Source: PLx Pharma Inc.