Baudax Bio, Inc. (Nasdaq: BXRX), a pharmaceutical company focused
on therapeutics for acute care settings, today announced the online
publication of data highlighting the safety and efficacy of
preoperative ANJESO® (meloxicam) injection in patients undergoing
unilateral total knee arthroplasty (TKA) when used within a
multimodal analgesic regimen, in the peer-reviewed medical journal
Pain Medicine. ANJESO is indicated for the management of moderate
to severe pain, alone or in combination with other non-NSAID
analgesics.
Preemptive administration allows providers to
better control pain at the outset of surgery, rather than waiting
until inflammation and pain have already set in. Preoperative use
of NSAIDs is recommended by the American Society for Enhanced
Recovery (ASER) and the Perioperative Quality Initiative (POQI).
Further multimodal analgesia involves the administration of 2 or
more drugs that act by different mechanism for providing analgesia,
the aim of which is to improve pain relief while reducing opioid
requirements and opioid-related adverse effects.
“Patients typically report high levels of pain
after orthopedic surgery and managing this pain can be challenging.
In this study we administered ANJESO prior to the start of the
surgery helping us to stay ahead of the pain. Which is a critical
component of patient care,” said Richard Berkowitz, M.D.,
University Orthopedic and Joint Replacement Center, Tamarac,
Florida. “In the past there has been a tendency to resort to
opioids for pain control, given the risks associated with opioids
such as addiction, gastrointestinal adverse events, pruritus, and
respiratory depression, among others, there has been an increased
need for alternative medications for patients undergoing elective
or nonelective surgical procedures and it is encouraging to see
these results.”
“The data published by Pain Medicine continues
to support ANJESO as an advantageous option for the management of
moderate to severe pain. The data not only highlight the efficacy
and tolerability of ANJESO when administered preoperatively within
a multimodal analgesic regimen to patients undergoing TKA, but also
conveys a decreased need for opioids following surgery,” said
Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax
Bio. “The findings are especially compelling because they suggest
select measures of health care resource utilization (HRU) also
tended to be lower in the ANJESO treated group, including 10% lower
mean total hospital charges. These data suggest ANJESO has a
promising role in multimodal analgesic regimens in this clinical
setting.”
Efficacy and Safety Results Following
Administration of Preoperative ANJESO Compared to
Placebo
During the 1st 24 hours, ANJESO patients used
~32% less opioids and reported ~22% greater pain reduction relative
to placebo treated patients. ANJESO-treated patients had a
significantly lower Summed Pain Intensity score on the first
postsurgical day and throughout their inpatient course (p≤0.0001).
Additionally, ANJESO-treated patients had significantly lower
opioid consumption during the first postsurgical day, with a 31.7%
reduction compared to placebo (mean 19mg vs. 28mg; p<0.0001).
Significant reductions in opioid use were observed on subsequent
days and throughout treatment. ANJESO-treated patients had a
significantly longer time to first opioid rescue after surgery
compared to placebo treated patients. ANJESO-treated subjects had
lower incidences of all cause hospital readmissions, fewer patients
admitted to skilled nursing facilities upon discharge, and fewer
emergency room visits, and doctor calls related to pain during the
follow-up period.
With respect to safety, adverse events (AEs)
were primarily mild or moderate in intensity and not related to
study treatment, with a higher incidence of AEs reported in the
placebo group. Additionally, the incidence of serious AEs was
higher in the placebo group. All serious AEs in the ANJESO group
were assessed by the primary investigators to be not related to
study treatment. No subject discontinued due to an AE. The overall
rate of AEs of special interest (AESI; events related to concerns
associated with NSAIDS) were lower in the ANJESO-treated group at
9.7% than the placebo group at 21.6%. Rates of individual events in
the ANJESO group occurred at similar or lower rates compared to the
placebo group. Laboratory and surgical wound healing assessments
were similar between treatment groups. This study supports the
efficacy and safety of ANJESO administered once daily, with
administration beginning prior to start of surgery, as part of a
standardized multimodal regimen in subjects undergoing primary
unilateral TKA.
Healthcare Resource Utilization (HRU)
Results Following Preoperative ANJESO Compared to
Placebo
This study also evaluated HRU and costs,
including total hospital costs, hospital length of stay (LOS),
hospital readmissions, ER visits, physician office visits, and
phone calls due to pain, associated with preoperative
administration of ANJESO compared to placebo, through postoperative
day 30. This study was not powered to show statistical differences
in HRU endpoints.
The total mean charges for the hospital stay,
and total overall charges were lower in the ANJESO group compared
to the placebo group, ($56,424 vs $62,864), however, the
differences were not statistically significant. Mean hospital LOS
in days was lower in the ANJESO group compared to the placebo group
(2.05 vs. 2.24 days), which was 8.6% lower compared to placebo,
however, the difference was not statistically significant. There
were fewer hospital readmissions (1 vs. 3), ER visits (0 vs. 4),
and phone calls due to pain (4 vs. 9) for ANJESO versus placebo,
respectively. There were no reports of unscheduled physician office
visits due to pain in either group.
Mean total opioid use from hour 0-24, 0-48, and
0-72 hours was significantly lower among meloxicam IV compared to
placebo (p<0.0001) and from hour 0 through hospital discharge
(33.28mg vs. 44.87mg); (p<0.001). Time to the first oral opioid
rescue medication was longer for the ANJESO group than placebo
(7.31 vs. 5.22 hours; p=0.0226) and a similar trend was observed
for mean time to first use of IV or oral opioid analgesia (4.75 vs.
3.09 hours; p=0.0126). While there was no significant association
between opioid consumption and total hospital charges, every unit
(1mg IV morphine equivalent) increase in opioid consumption was
associated with a 0.5% increase in LOS in days (p=0.0001). The
proportion of subjects with ≥1 opioid related adverse drug effects
were significantly higher for placebo than ANJESO (70.5% vs. 48.4%;
p=0.003). Six ANJESO-treated patients (6.5%) had ≥1 AESI in
comparison to 12 placebo subjects (13.6%). Serious AEs were
observed among 3 ANJESO-treated patients (3.2%) and 9 placebo
subjects (10.2%).
The Overall Benefit of Analgesia Scores (OBAS)
were also assessed. The OBAS is a simple, multi-dimensional quality
assessment instrument to measure patients’ benefit from
postoperative pain therapy. Opioid symptom distress, pain relief,
and patients’ satisfaction are combined in a reliable and valid
tool. A lower score indicates better pain management and lower
opioid symptom distress. The OBAS score was significantly lower for
meloxicam IV compared with placebo-treated subjects on the first
postoperative day (LS mean [SE] 4.45 [0.360] vs 5.90 [0.375] for
meloxicam and placebo, respectively; difference [95% CI], –1.45
[–2.39, –0.51]; P = 0.0027).
ANJESO®
Phase IIIb Study Design
The study was designed to evaluate the effect of
perioperative meloxicam IV on opioid consumption in primary TKA.
This was a multicenter, randomized, double-blind,
placebo-controlled trial and evaluated 181 adults undergoing
elective primary TKA. Subjects received meloxicam 30 mg or placebo
via IV bolus every 24 hours, with the first dose administered prior
to surgery as part of a multimodal pain management protocol. The
primary efficacy parameter was total opioid use over a 24-hour
period following surgery. Findings from the study suggest
perioperative meloxicam IV 30 mg as part of a multimodal analgesic
regimen for elective primary TKA reduced opioid consumption in the
24-hour period following surgery versus placebo and was associated
with a lower incidence of AEs typically associated with opioid
use.
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 was launched in the U.S. in June 2020 following its approval
by the Food and Drug Administration in February 2020. 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 therapeutics for acute care settings. The launch of Baudax Bio’s
first commercial product ANJESO® began in June 2020 following its
approval by the U.S. Food and Drug Administration in February 2020.
ANJESO is a once daily IV NSAID with preferential Cox-2 activity,
which has successfully completed three Phase III clinical trials,
including two pivotal efficacy trials, a large double-blind Phase
III safety trial and other studies for the management of moderate
to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of
other pharmaceutical assets including two novel neuromuscular
blocking agents (NMBAs) and a proprietary chemical reversal agent
specific to these NMBAs which is currently in preclinical studies,
and intranasal dexmedetomidine which is being developed for
possible uses in pain or sedation. For more information, please
visit www.baudaxbio.com.
INDICATION
ANJESO is indicated for use in adults for the
management of moderate-to-severe pain, alone or in combination with
non-NSAID analgesics.
Limitation of Use: Because of delayed onset of
analgesia, ANJESO alone is not recommended for use when rapid onset
of analgesia is required.
IMPORTANT SAFETY
INFORMATION
WARNING: RISK OF SERIOUS CARDIOVASCULAR
AND GASTROINTESTINAL EVENTS
Cardiovascular Risk
- Non-steroidal anti-inflammatory
drugs (NSAIDs) cause an increased risk of serious cardiovascular
thrombotic events, including myocardial infarction and stroke,
which can be fatal. This risk may occur early in treatment and may
increase with duration of use.
- ANJESO is contraindicated in the
setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
- NSAIDs cause an increased risk of
serious gastrointestinal (GI) adverse events including bleeding,
ulceration, and perforation of the stomach or intestines, which can
be fatal. These events can occur at any time during use and without
warning symptoms. Elderly patients and patients with a prior
history of peptic ulcer disease and/or GI bleeding are at greater
risk for serious GI events.
CONTRAINDICATIONS
ANJESO is contraindicated in patients with:
- Known hypersensitivity (eg,
anaphylactic reactions and serious skin reactions) to meloxicam or
any components of the drug product.
- History of asthma, urticaria, or
other allergic-type reactions after taking aspirin or other
NSAIDs.
- In the setting of coronary artery
bypass graft (CABG) surgery.
- Moderate to severe renal
insufficiency patients who are at risk for renal failure due to
volume depletion.
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Elevations of ALT or AST have
been reported in patients with NSAIDs. In addition, rare, sometimes
fatal, cases of severe hepatic injury including fulminant
hepatitis, liver necrosis, and hepatic failure have been reported.
Inform patients of warning signs and symptoms of hepatotoxicity.
Discontinue ANJESO immediately if abnormal liver tests persist or
worsen or if clinical signs and symptoms of liver disease
develop.
Hypertension: NSAIDs including ANJESO can lead
to new onset of hypertension or worsening of preexisting
hypertension, which may contribute to the increased incidence of
cardiovascular (CV) events. Patients taking some antihypertensive
medications may have impaired response to these therapies when
taking NSAIDs. Monitor blood pressure.
Heart Failure and Edema: NSAID use increased the
risk of myocardial infarction (MI), hospitalization for heart
failure, and death. Avoid use of ANJESO in patients with severe
heart failure unless benefits are expected to outweigh risk of
worsening heart failure. If ANJESO is used in patients with severe
heart failure, monitor patients for signs of worsening heart
failure.
Post MI Patients: Avoid the use of ANJESO in
patients with recent MI unless the benefits are expected to
outweigh the risk of recurrent CV thrombotic events. If ANJESO is
used in these patients, monitor for signs of cardiac ischemia.
Renal Toxicity: Long-term administration of
NSAIDs has resulted in renal papillary necrosis, renal
insufficiency, acute renal failure, and other renal injury. ANJESO
is not recommended in patients with moderate to severe renal
insufficiency and is contraindicated in patients with moderate to
severe renal insufficiency who are at risk for renal failure due to
volume depletion. Correct volume status in dehydrated or
hypovolemic patients prior to initiating ANJESO. Monitor renal
function in patients with renal or hepatic impairment, heart
failure, dehydration, or hypovolemia. Avoid use of ANJESO in
patients with advanced renal disease unless benefits are expected
to outweigh risk of worsening renal function. If ANJESO is used in
patients with advanced renal disease, monitor patients for signs of
worsening renal function.
Anaphylactic Reactions: Meloxicam has been
associated with anaphylactic reactions in patients with and without
known hypersensitivity to meloxicam and in patients with
aspirin-sensitive asthma. Seek emergency help if an anaphylactic
reaction occurs.
Exacerbation of Asthma Related to Aspirin
Sensitivity: ANJESO is contraindicated in patients with
aspirin-sensitive asthma. Monitor patients with preexisting asthma
(without aspirin sensitivity).
Serious Skin Reactions: NSAIDs, including
ANJESO, can cause serious skin reactions, including exfoliative
dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal
necrolysis (TEN), which can be fatal and can occur without warning.
Discontinue ANJESO at first appearance of skin rash or other signs
of hypersensitivity.
Hematologic Toxicity: Anemia has occurred in
NSAID-treated patients. Monitor hemoglobin or hematocrit in
patients with any signs or symptoms of anemia. NSAIDs, including
ANJESO, may increase the risk of bleeding events. Monitor patients
for signs of bleeding.
DRUG INTERACTIONS
Drugs That Interfere with Hemostasis (e.g.,
warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who
are concomitantly taking ANJESO with drugs that interfere with
hemostasis. Concomitant use of ANJESO and analgesic doses of
aspirin is not generally recommended.
Angiotensin Converting Enzyme (ACE) Inhibitors,
Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant
use with ANJESO may diminish the antihypertensive effect of these
drugs. Monitor blood pressure.
ACE Inhibitors and ARBs: Concomitant use with
ANJESO in elderly, volume depleted, or those with renal impairment
may result in deterioration of renal function. In such high risk
patients, monitor for signs of worsening renal function.
Diuretics: NSAIDs can reduce natriuretic effect
of furosemide and thiazide diuretics. Monitor patients to ensure
diuretic efficacy including antihypertensive effects.
ADVERSE REACTIONS
The most common adverse reactions in controlled
clinical trials occurring in ≥ 2% of patients treated with ANJESO
and at a greater frequency than placebo include: constipation,
gamma-glutamyl transferase increased, and anemia.
USE IN SPECIFIC POPULATIONS
Pregnancy: Use of NSAIDs during the third
trimester of pregnancy increases the risk of premature closure of
the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women
starting at 30 weeks gestation.
Infertility: NSAIDs are associated with
reversible infertility. Consider withdrawal of ANJESO in women who
have trouble conceiving.
Please see full Prescribing Information,
including Boxed Warning
at www.anjeso.com.
Cautionary Statement Regarding 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 and are subject to a number of
risks, uncertainties, and other factors that could cause Baudax
Bio’s performance to differ materially from those expressed in, or
implied by, these forward-looking statements. These forward-looking
statements are subject to risks and uncertainties including, among
other things, the completion of the registered direct offering and
the intended use of proceeds from the registered direct offering,
the ongoing economic and social consequences of the COVID-19
pandemic, including any adverse impact on the commercial launch of
ANJESO® or disruption in supply chain, Baudax Bio’s ability to
maintain regulatory approval for ANJESO, Baudax Bio’s ability to
successfully commercialize ANJESO; the acceptance of ANJESO by the
medical community, including physicians, patients, health care
providers and hospital formularies; Baudax Bio’s ability and that
of Baudax Bio’s third party manufacturers to successfully scale-up
our commercial manufacturing process for ANJESO, Baudax Bio’s
ability to produce commercial supply in quantities and quality
sufficient to satisfy market demand for ANJESO, Baudax Bio’s
ability to raise future financing for continued product
development, payment of milestones and ANJESO commercialization,
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 our
operational and budget plans, the accuracy of Baudax Bio’s
estimates of the potential market for ANJESO, 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 / Claudia
Styslinger(212) 600-1902baudaxbio@argotpartners.com
Media Contact:Argot PartnersDavid Rosen(212)
600-1902david.rosen@argotpartners.com
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