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
October 14 2021 - 12:27PM
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.
About VAZALORE
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.
Forward-Looking Statements
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.
ContactInvestor Relations:Lisa
M. Wilson, In-Site Communications, Inc.T: 212-452-2793E:
lwilson@insitecony.com
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