PLx Pharma Inc. Announces New Scientific Data Available Evaluating the Pharmacologic Profile of FDA-Approved VAZALORE 81 mg Liquid-Filled Aspirin Capsules
November 04 2021 - 8:50AM
PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), is a
specialty pharmaceutical company focused on its
clinically-validated and patent-protected PLxGuardTM drug delivery
platform that has the potential to improve the absorption of many
drugs currently on the market and to reduce the risk of stomach
injury associated with certain drugs. The Company, with its lead
products VAZALORETM 325 mg and VAZALORETM 81 mg liquid-filled
aspirin capsules (referred to together as “VAZALORE”), today
announced the availability of additional scientific data that
builds upon the pharmacokinetic (PK) and pharmacodynamic (PD)
profiles of VAZALORE 81 mg and compared with enteric coated aspirin
(EC-ASA).
PLx Pharma conducted a randomized, open-label, crossover study
where preliminary results showed VAZALORE 81 mg provided fast and
reliable absorption after a single dose. In addition, VAZALORE 81
mg provided potent and early inhibition of platelet aggregation.
The results of this study titled, Pharmacokinetic and
Pharmacodynamic Profile of PL-ASA, a Novel Phospholipid-Aspirin
Complex Liquid Formulation, Compared to Enteric-coated Aspirin at
an 81 mg Dose – Results from a Prospective, Randomized Crossover
Study (F. Franchi et al.), were included in a virtual poster
presentation during the Transcatheter Cardiovascular Therapeutics
Meeting of the Cardiovascular Research Foundation (TCT 2021) in
Orlando, FL. To access the poster, click here
https://tct2021.crfconnect.com/abstracts, register and once
signed in, search for abstract ‘TCT 320’ or author ‘Franchi’ to
view the pdf.
“This was the first study to investigate the PK/PD parameters of
the 81 mg dose of VAZALORE and, as expected, the results were
consistent with previous findings from published pharmacologic
studies with the 325 mg,” said Lead Investigator Francesco Franchi,
M.D., Assistant Professor of Medicine – Department of Medicine,
Division of Cardiology at the University of Florida College of
Medicine –Jacksonville.
“We are excited that these findings provide additional clinical
information about our FDA-approved VAZALORE liquid-filled aspirin
capsules, beyond the first studies that supported approval of
VAZALORE 81 mg and VAZALORE 325 mg,” said Natasha Giordano,
President and CEO of PLx Pharma.
About VAZALOREVAZALORE is an
FDA-approved liquid-filled aspirin capsule, available in 81 mg and
325 mg doses. 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 for pain relief plus the lifesaving benefits of aspirin.
To learn more about VAZALORE, please
visit www.vazalore.com.
About PLx Pharma Inc. PLx
Pharma, Inc. is a specialty pharmaceutical company focused on
improving how active pharmaceutical ingredients (APIs) are absorbed
in the gastrointestinal (GI) tract via its clinically validated and
patent protected PLxGuard™ drug delivery platform. 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 injury associated with certain drugs. To
learn more about PLx Pharma Inc. and its pipeline, please
visit www.plxpharma.com.
Forward-Looking StatementsAny
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
Source: PLx Pharma Inc.
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