Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on
therapeutics for acute care settings, today announced that the U.S.
Food and Drug Administration (FDA) has approved the New Drug
Application (NDA) for ANJESO™ (meloxicam injection), which is
indicated for the management of moderate to severe pain, alone or
in combination with other non-NSAID analgesics.
“The approval of ANJESO marks a major
advancement in the treatment landscape for managing moderate to
severe pain,” said Gerri Henwood, President and Chief Executive
Officer of Baudax Bio. “With our nation currently in the midst of a
national opioid epidemic, we are thrilled to be able to offer a
novel, non-opioid therapeutic option with the potential to
meaningfully impact the acute pain treatment paradigm. We
expect to make ANJESO available to physicians and patients in late
April or early May 2020.”
ANJESO is approved for the management of
moderate to severe pain and will be administered as a once-a-day
intravenous (IV) bolus push. ANJESO is the only available 24-hour,
intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory
(NSAID) and 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.
“The safety and efficacy of ANJESO have been
well-established through several mid- and late-stage clinical
studies,” said Stewart McCallum, M.D., Chief Medical Officer of
Baudax Bio. “Moreover, data from our Phase III safety trial
demonstrated that ANJESO is well tolerated and impacted opioid
consumption compared to placebo, further highlighting its value to
patients, providers and health systems.”
“The approval of ANJESO marks an important
achievement for the medical community given the unmet need for
non-opioid options in the pain treatment landscape,” said Dr. Keith
Candiotti chair of the Department of Anesthesiology, Perioperative
Medicine and Pain Management at the University of Miami.
“While traditional opioid medications have proven effective at
providing pain relief, the associated adverse side effects,
including sedation and respiratory depression, have driven
physicians to employ a multi-modal approach to treating
post-operative pain. With 24-hour, durable pain relief and a safety
profile comparable to placebo, ANJESO has the potential to serve as
a meaningfully differentiated analgesic alternative.”
The ANJESO approval is supported by two Phase
III efficacy studies and one double-blind, placebo-controlled Phase
III safety study. The results from these studies, as well as
results from four Phase II clinical studies and other safety
studies, comprised the NDA package.
The most common ADVERSE REACTIONS reported in
≥2% of patients treated with ANJESO and at a greater frequency than
placebo included: constipation, gamma-glutamyl transferase
increased and anemia.
Please see “News & Investors” section of the
Company’s website at www.baudaxbio.com for full Prescribing
Information in addition to the full Important Safety Information
provided below.
Baudax expects ANJESO will be available in the U.S. in late
April or early May 2020. For more information, visit
www.baudaxbio.com.
Conference Call and Webcast
Baudax Bio management will be hosting a
conference call and webcast today beginning at 4:30 p.m. ET. To
access the conference call, please dial (866) 220-5595 (local) or
(615) 622-8062 (international) at least 10 minutes prior to the
start time and refer to conference ID 4373423.A live audio webcast
of the call will be available under "Events" in the Investor
section of the Company's website,
https://www.baudaxbio.com/news-and-investors/events. An archived
webcast will be available on the Company's website approximately
two hours after the event and will be available for 30 days.
ANJESO™ COMPREHENSIVE CLINICAL
TRIALS
Phase 3 Efficacy Study
Evaluating ANJESO Following Bunionectomy Surgery
In this multicenter, randomized, double-blind,
placebo-controlled clinical trial, 201 patients were enrolled and
randomly assigned to receive a postoperative regimen of ANJESO
(30mg) or placebo in a 1:1 ratio, once every 24 hours for up to 3
doses following bunionectomy surgery, a representative hard tissue
surgery. The ANJESO treatment arm demonstrated a statistically
significant reduction in SPID48 (p=0.0034) compared to the placebo
arm. The study also achieved 15 of the 19 secondary endpoints,
including statistically significant differences in SPID6
(p=0.0153), SPID12 (p=0.0053), SPID24 (p=0.0084), SPID24-48
(p=0.0050), time to first use of rescue medication (p=0.0076), and
several other rescue use and pain relief metrics during the first
48 hours, compared to placebo. The safety results demonstrated that
ANJESO was well tolerated with no serious adverse events or
bleeding events in the ANJESO-treated patients.
Phase 3 Efficacy Study
Evaluating ANJESO Following Abdominoplasty
Surgery
In this multicenter, randomized, double-blind,
placebo-controlled clinical trial, 219 patients were enrolled and
randomly assigned to receive a postoperative regimen of ANJESO
(30mg bolus injection) or placebo in a 1:1 ratio, once every 24
hours. The ANJESO treatment arm demonstrated a statistically
significant reduction in SPID24 (p=0.0145) compared to the placebo
arm. The study also achieved statistical significance for 10
of the secondary endpoints, including statistically significant
differences in SPID12 (p=0.0434), time to perceptible pain relief
(p=0.0050), subjects with ≥30% improvement at 24 hours (p=0.0178),
number of times patients required rescue in the first 24 hours
after randomization (p=0.0275), as well as number of times rescued
from 24 to 48 hours (p=0.0009), and several other pain relief
metrics, compared to placebo. The safety results demonstrated that
ANJESO was well tolerated with no difference in serious adverse
events (SAEs) related to bleeding for ANJESO treated patients
versus placebo (1 each).
Phase 3 Safety Study Evaluating ANJESO
Following Major Surgery
This multicenter, randomized, double-blind,
placebo-controlled Phase III clinical trial, included patients who
had undergone major elective surgical procedures which were
expected to result in hospitalization for at least 24-48 hours.
Major surgical procedures included total hip and knee replacements,
spinal, GI, hernia repair, and gynecologic surgeries, as well as a
range of other surgeries. Patient demographics were balanced
across treatment groups and included 40% male patients and about
23% of patients who were over age 65. Unlike the pivotal
efficacy trials, minimum pain scores were not required for
treatment. Sites were permitted to use opioids and other pain
management modes according to their “standard of care” and
meloxicam or placebo was added to this regimen. Patients were
randomized in a 3:1 ratio to receive either ANJESO or IV placebo
daily for up to 7 doses. A total of 721 patients received at
least one dose of study medication. In patients age 65 and over,
the percentage of patients reporting at least one AE was
approximately 7% less in the ANJESO treatment arm compared to the
placebo arm. The total occurrence of patients with at least
one serious adverse event (SAE) was observed to be lower in the
ANJESO group, 2.6%, (14/538 meloxicam patients) than in the placebo
group, 5.5%, (10/183 placebo patients). In this safety study
only two SAE events were listed as possibly related to study
treatment. Both of these SAEs occurred in one placebo treated
patient. No deaths were reported in either treatment group.
Approximately 3% of patients in each study group discontinued.
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.baudaxbio.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 to launch ANJESO in late April or early
May 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 lead
product candidate is a proprietary intravenous (IV) form of
meloxicam, a non-opioid, once a day preferential COX-2 inhibitor.
IV meloxicam has successfully completed two pivotal Phase III
clinical efficacy trials, a large double-blind placebo-controlled
Phase III safety trial, four Phase II clinical efficacy trials, as
well as other safety studies. 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 this
press release 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, our ability to maintain regulatory approval for
ANJESO™, our ability to successfully commercialize ANJESO™;
the acceptance of ANJESO™ by the medical community, including
physicians, patients, health care providers and hospital
formularies; our ability and that of our third party manufacturers
to successfully scale-up our commercial manufacturing process for
ANJESO™, our ability to produce commercial supply in quantities and
quality sufficient to satisfy market demand for ANJESO™, our
ability to raise future financing for continued product development
and ANJESO™ commercialization, our ability to manage costs and
execute on our operational and budget plans, the accuracy of our
estimates of the potential market for ANJESO™, our ability to
achieve our financial goals; and our 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.
The forward-looking statements in this press release 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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