Baudax Bio Initiates Phase IV Clinical Trial Evaluating ANJESO® in Pediatric Patients Following Surgery
March 08 2022 - 8:00AM
Baudax Bio, Inc. (NASDAQ:BXRX) a pharmaceutical company focused on
commercializing and developing innovative products for acute care
settings, today announced initiation of a clinical study evaluating
the safety and pharmacokinetics (PK) of ANJESO (meloxicam)
injection in pediatric patients (ages 2 to <17 years old)
following surgery.
This multicenter, open-label clinical trial will
study ANJESO in multiple age groups of children who undergo
elective surgery in either an inpatient or outpatient setting.
Approximately 90 patients will be enrolled across three age groups
(12 to <17, 7 to <12 and 2 to <7 years old) to establish
safety for all three age groups. All enrolled patients will be
included in the safety assessment and analyses, while PK will be
assessed using a subset of each age group (12 patients per age
group). Patients will undergo elective surgery on Day 1 with
appropriate anesthesia according to the investigator’s clinical
standard of care practice and in accordance with institutional
standards. At the end of the surgical procedure, each patient will
receive their first dose of ANJESO as an IV bolus injection,
according to the weight of the patient. Additional doses may be
administered every 24 hours and patients may receive a maximum of
three doses of ANJESO in the study. PK endpoints for determination
of ANJESO concentrations in plasma will be based on population PK
analysis.
“We are extremely pleased to initiate this
important new clinical study in pediatric patients following
elective surgery, and look forward to elucidating ANJESO’s safety
and PK profile in these younger patients who undergo an estimated
3.9 million elective surgeries in the U.S. each year, from the
simple, such as appendectomies and herniorrhaphies to complex
thoracic, gastrointestinal, orthopedic, and genitourinary,
surgeries,” said Gerri Henwood, Baudax Bio’s President and Chief
Executive Officer. “ANJESO continues its upward growth in the
marketplace in adult patients and as an important non-opioid pain
management option, we believe it has significant potential for
pediatric patients as well.”
About ANJESO®
ANJESO (meloxicam) injection is a proprietary,
long-acting, preferential COX-2 inhibitor that possesses analgesic,
anti-inflammatory and antipyretic activities, which are believed to
be related to the inhibition of cyclooxygenase type 2 pathway
(COX-2) and subsequent reduction in prostaglandin biosynthesis.
ANJESO is indicated for the management of moderate to severe pain,
alone or in combination with other non-NSAID analgesics. Because of
the delayed onset of analgesia, ANJESO alone is not recommended for
use when rapid onset of analgesia is required. ANJESO is supported
by two pivotal Phase III clinical efficacy trials, a large
double-blind, placebo-controlled Phase III safety trial and four
Phase II clinical efficacy trials, as well as other safety studies.
As a non-opioid, Baudax Bio believes ANJESO has the potential to
overcome many of the issues associated with commonly prescribed
opioid therapeutics, including respiratory depression,
constipation, excessive nausea and vomiting, as well as having no
addictive potential, while maintaining meaningful analgesic effects
for relief of pain. ANJESO was designed using the NanoCrystal®
platform, a technology that enables enhanced bioavailability of
poorly water-soluble drug compounds. NanoCrystal® is a registered
trademark of Alkermes Pharma Ireland Limited (APIL).
About Baudax Bio
Baudax Bio is a pharmaceutical company focused
on commercializing and developing innovative products for acute
care settings. ANJESO is the first and only 24-hour, intravenous
(IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for
the management of moderate to severe pain. In addition to ANJESO,
Baudax Bio has a pipeline of other innovative pharmaceutical assets
including two novel neuromuscular blocking agents (NMBAs) and a
proprietary chemical reversal agent specific to these NMBAs. For
more information, please visit www.baudaxbio.com.
Forward-Looking Statements
This press release contains forward-looking
statements that involve risks and uncertainties. Such
forward-looking statements reflect Baudax Bio’s expectations about
its future performance and opportunities that involve substantial
risks and uncertainties. When used herein, the words “anticipate,”
“believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,”
“intend,” and “expect,” and similar expressions, as they relate to
Baudax Bio or its management, are intended to identify such
forward-looking statements. These forward-looking statements are
based on information available to Baudax Bio as of the date of
publication on this internet site, including Baudax Bio’s ability
to realize any anticipated benefits from the reverse stock split,
including maintaining its listing on the Nasdaq Capital Market and
attracting new investors. These risks and uncertainties include,
among other things, risks related to the ongoing economic and
social consequences of the COVID-19 pandemic, Baudax Bio’s ability
to advance its current product candidate pipeline through
pre-clinical studies and clinical trials, Baudax Bio’s ability to
raise future financing for continued development of its product
candidates such as BX-1000, BX-2000 and BX-3000, Baudax Bio’s
ability to pay its debt and satisfy conditions necessary to access
future tranches of debt, Baudax Bio’s ability to comply with the
financial and other covenants under its credit facility, Baudax
Bio’s ability to manage costs and execute on its operational and
budget plans, Baudax Bio’s ability to achieve its financial goals,
and Baudax Bio’s ability to obtain, maintain and successfully
enforce adequate patent and other intellectual property protection.
These forward-looking statements should be considered together with
the risks and uncertainties that may affect Baudax Bio’s business
and future results included in Baudax Bio’s filings with the
Securities and Exchange Commission at www.sec.gov. These
forward-looking statements are based on information currently
available to Baudax Bio, and Baudax Bio assumes no obligation to
update any forward-looking statements except as required by
applicable law.
CONTACT:
Investor Relations Contact:
Argot PartnersSam Martin / Kaela Ilami(212)
600-1902baudaxbio@argotpartners.com
Media Contact:
Argot PartnersDavid Rosen(212)
600-1902david.rosen@argotpartners.com
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