PLx Pharma Inc. Presents Original Abstract and Simultaneous Publication of its Novel, Liquid-Filled Capsule Aspirin Formulation at the 2020 International Stroke Conference
02/21/2020 | 06:51am EDT
SPARTA, N.J., Feb. 21, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), a late-stage specialty pharmaceutical company focused on developing more effective and safer products with its patent-protected PLxGuard™ delivery system, announced today the presentation of an original poster on VAZALORE™ 325 mg at the 2020 International Stroke Conference, the premier meeting dedicated to the science and treatment of cerebrovascular disease and brain health, and the simultaneous publication in the Journal of Thrombosis and Thrombolysis.
Abstract Title: Bioavailability of Aspirin in Fasted and Fed States of a Novel Formulation of a Pharmaceutical Lipid-Aspirin Complex
Session Date: Thursday, February 20, 2020, 6:30 PM Pacific Standard Time
Presenter: 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.
Study Design In this randomized, open label, crossover study, 20 healthy volunteers fasted for at least ten hours and were then randomized as either “fasted,” receiving 650 mg of PL-ASA, or as “fed,” with a standard high-fat meal and 650 mg of PL-ASA 30 minutes later. After a washout of seven days, participants crossed over to the other arm. The primary outcome was comparison of pharmacokinetic (PK) parameters of the stable aspirin metabolite salicylic acid (SA) between fasted and fed states. The results established that PL-ASA may be co-administered with food without significant impact on aspirin bioavailability.
“The data presented at the International Stroke Conference demonstrate that VAZALORE, with its novel delivery platform in a liquid-filled capsule, can deliver aspirin reliably irrespective of whether it is taken on an empty stomach or with food. These findings are clinically important since many clinicians recommend that aspirin be taken with food in order to reduce dyspeptic symptoms, a practice that can lead to erratic aspirin absorption, especially with coated aspirin formulations,” stated Dr. Angiolillo, the lead author of the Journal of Thrombosis and Thrombolysis publication released simultaneously with the presentation.
“Aspirin continues to be the cornerstone of lifelong antithrombotic protection for patients with established atherosclerotic cardiovascular disease. The data presented here, and now published, complement previous studies with this lipid-based formulation of aspirin. It is encouraging that a new formulation of aspirin combining both reliable absorption and antiplatelet effect with improved gastrointestinal safety may soon be available for our patients,” added Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC, Executive Director of Interventional Cardiovascular Programs Brigham and Women’s Hospital Heart & Vascular Center, Professor of Medicine, Harvard Medical School, and Chairman of the PLx Scientific Advisory Board.
“VAZALORE continues to deliver outstanding results that address important unmet clinical needs of the currently available aspirin formulations. We believe that VAZALORE has the potential to address the long-standing need for a new, better aspirin product, and we will continue our efforts to make VAZALORE available to the millions of high-risk cardiovascular patients who require reliable lifelong vascular protection,” concluded Efthymios N. Deliargyris, MD, FACC, FESC, FSCAI, Chief Medical Officer of PLx Pharma.
About VAZALORE VAZALORE 325 mg is an FDA-approved aspirin product developed to provide patients with vascular disease and diabetic patients who are candidates for aspirin therapy with more reliable and predictable antiplatelet efficacy as compared to enteric-coated aspirin, while also reducing the adverse gastric events common in an acute setting. PLx is focused on manufacturing, scale-up and preparing an sNDA for VAZALORE 81 mg maintenance dose form.
About PLx Pharma Inc. PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients (API) to various portions of the gastrointestinal (GI) tract. PLx believes this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce GI side effects—including erosions, ulcers and bleeding—associated with aspirin and ibuprofen, and potentially other drugs.
To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.
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