PLx Pharma, Inc. Issues Statement on Recent USPTF Recommendations on Aspirin Therapy for Primary Prevention of Cardiovascular Disease; PLx's VAZALORE Specifically Indicated for Secondary Prevention
10/14/2021 | 01:28pm EST
SPARTA, N.J., Oct. 14, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products, with its lead products VAZALORE™ 325 mg and VAZALORE™ 81 mg liquid-filled aspirin capsules (referred to together as “VAZALORE”), today issued a statement on recent United States Preventive Services Task Force (“USPTF”) recommendations on aspirin therapy for primary prevention of cardiovascular disease.
There has been some confusion regarding recent reports in the media regarding the USPTF recommended guidelines on the use of aspirin in primary prevention of cardiovascular disease. The draft recommendations issued by the USPTF pertain to the use of aspirin for the prevention of a first cardiovascular event, and do not pertain to those who have already had a cardiovascular event, such as a heart attack or clot-related stroke and are taking aspirin based on their doctor’s recommendation.
“VAZALORE’s targeted population is those patients with a history of cardiovascular disease and who are already on a physician prescribed aspirin therapy to help prevent another heart attack or clot-related stroke,” said Natasha Giordano, President and CEO of PLx Pharma. “As cardiologists continue to recommend aspirin for their cardiovascular disease patients, VAZALORE is an innovative aspirin with its unique delivery system designed to help protect the stomach. We strongly recommend patients consult with their doctors before starting or stopping aspirin therapy.”
Several years ago, the American College of Cardiology and the American Heart Association updated their recommendations to limit the use of aspirin in patients without established cardiovascular disease. Their recommendations, which are closely followed by cardiologists, state that aspirin is an established practice for the secondary prevention of a heart attack or clot-related stroke.
VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule allows for targeted release of aspirin, limiting its direct contact with the stomach. VAZALORE delivers fast, reliable absorption to help prevent another heart attack or clot-related stroke.
Millions of people take aspirin daily as part of a physician-prescribed aspirin therapy plan following a heart attack or clot-related stroke. In addition, many patients with a history of GI issues reported discontinuing aspirin therapy against medical advice because of “stomach issues.” VAZALORE has been clinically shown to cause fewer gastric erosion/ulcers versus immediate release aspirins as shown in clinical trials.*
* Clinically shown on VAZALORE 325 mg after 7 days of treatment; Cryer B, et al. Low-Dose Aspirin-Induced Ulceration is Attenuated by Aspirin-Phosphatidylcholine: A Randomized Clinical Trial. Am J Gastroenterol 2011; 106(2):272-7.
VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. To learn more about VAZALORE, please visit www.vazalore.com.
About PLx Pharma Inc.
PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.
To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any products or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to PLx may identify forward-looking statements. PLx cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by PLx to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of PLx’s proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property, risks that PLx may lack the financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect PLx’s business, financial conditions and results of operations are contained in PLx’s filings with the U.S. Securities and Exchange Commission (“SEC”), which are available at www.sec.gov. Other risks and uncertainties are more fully described in PLx’s Form 10-K for the year ended December 31, 2020 filed with the SEC on March 12, 2021, and in other filings that PLx has made or will make going forward. The forward-looking statements represent PLx’s estimate as of the date hereof only, and PLx specifically disclaims any duty or obligation to update forward-looking statements.
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