Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on
therapeutics for acute care settings, today announced that ANJESO™
(meloxicam) injection, the only 24-hour, intravenous (IV) COX-2
preferential non-steroidal anti-inflammatory drug (NSAID), is now
available for ordering and delivery to customers. ANJESO was
approved by the U.S. Food and Drug Administration (FDA) on February
20, 2020 and is indicated for the management of moderate to severe
pain, alone or in combination with other non-NSAID
analgesics.
“We are delighted to announce the availability
of ANJESO for ordering and delivery in the U.S.,” said Gerri
Henwood, President and Chief Executive Officer of Baudax Bio.
“These are challenging times for everyone involved in the
delivery of healthcare in the United States and the well-being of
everyone involved remains our top priority. I am pleased with
the virtual outreach our current commercial team has been
conducting and we believe ANJESO is a major advancement in the
physician’s armamentarium for managing moderate to severe pain for
a wide variety of surgical procedures. We are excited to
offer this novel, non-opioid therapeutic option that has the
potential to transform the acute pain treatment paradigm. We
are diligently working to hire and train our field sales force and
expect to execute the full ANJESO commercial launch by later in the
2nd quarter.”
ANJESO is administered as a once-a-day
intravenous (IV) bolus push. ANJESO is the only available 24-hour,
IV COX-2 preferential NSAID that offers once-daily dosing.
The active ingredient meloxicam is a 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.
For more information about ANJESO, visit www.ANJESO.com or call
1-855-405-9983.
INDICATION AND USAGE
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
EVENTSCardiovascular
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 Enzymes (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.
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 approved by the U.S. Food and Drug Administration
in February 2020 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.
The Company expects full commercial launch of ANJESO by
late Q2 2020. The ANJESO product approval was 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, Inc.
Baudax Bio is a specialty pharmaceutical company
focused on therapeutics for acute care settings. The Company’s
first commercial product, ANJESO™, had its New Drug Application
approved by FDA on February 20, 2020 for the management of moderate
to severe pain, alone or in combination with other non-NSAID
analgesics. 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. As a non-opioid, IV meloxicam 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. For more information please visit
www.baudaxbio.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. Baudax Bio assumes no
obligation to update any such forward-looking statements. These
forward-looking statements are subject to risks and uncertainties
including, among other things, 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 and ANJESO™
commercialization, 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 our business and future results included in our filings
with the Securities and Exchange Commission at www.sec.gov. These
forward-looking statements are based on information currently
available to us, and we assume no obligation to update any
forward-looking statements except as required by applicable law.
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.
CONTACT:
Investor Relations Contact: Argot PartnersSam Martin / Claudia
Styslinger(212) 600-1902sam@argotpartners.com
claudia@argotpartners.com
Baudax Bio, Inc. Ryan D. Lake (484) 395-2436
rlake@baudaxbio.com
Media Contact: Argot Partners David Rosen (212) 600-1902
david.rosen@argotpartners.com
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