Baudax Bio Announces PDUFA Date for Intravenous Meloxicam
January 22 2020 - 7:00AM
Baudax Bio, Inc. (NASDAQ:BXRX), a specialty pharmaceutical company
focused on therapeutics for acute care settings, today announced
that the U.S. Food and Drug Administration (FDA) has set a PDUFA
goal date of February 20, 2020 for its decision on the New Drug
Application (NDA) for intravenous (IV) meloxicam for the management
of moderate to severe pain. The assignment of this PDUFA goal date
follows the FDA’s acceptance of Baudax’s latest complete response
package relating to its 2019 complete response letter (CRL) and
appeal filing, seeking approval for IV meloxicam.
“We are pleased by the FDA’s acceptance of our
latest response package, which we believe addresses their concerns
and which includes proposed labeling for IV meloxicam for the
management of moderate to severe pain, alone or in combination with
other analgesics,” said Gerri Henwood, President and Chief
Executive Officer of Baudax Bio. “We will be working closely with
the FDA as they complete their review of the IV meloxicam NDA and
work toward the PDUFA goal date.”
In October 2019, Baudax (through its former
parent, Recro Pharma, Inc.) received a written decision from the
FDA granting the appeal of the CRL the Company had previously
received (in March of 2019) relating to its IV meloxicam NDA.
About Intravenous Meloxicam
Baudax holds exclusive global rights to
Intravenous (IV) meloxicam, an NDA-pending non-opioid analgesic
developed for the treatment of moderate to severe pain. If
approved, IV meloxicam will be a novel IV non-opioid option for
patients with moderate to severe pain. IV meloxicam successfully
completed three Phase III clinical studies, including two Phase III
efficacy studies and one Phase III safety study, four Phase II
clinical studies, as well as other safety studies. The active
ingredient meloxicam is a long-acting, preferential COX-2 inhibitor
that exhibits analgesic, anti-inflammatory and antipyretic
activities, which are believed to be related to the inhibition of
cyclooxygenase (COX) and subsequent reduction in prostaglandin
biosynthesis. IV meloxicam 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 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, long-acting 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. Upon IV meloxicam approval, ANJESOTM,
will be a novel non-opioid option 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,"
"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. Factors that could
cause Baudax Bio’s actual performance to materially differ from
those expressed in the forward-looking statements set forth in this
press release include, without limitation: the Company’s ability to
execute its strategy for further development and commercialization
of IV meloxicam, the Company’s ability to execute its strategic
initiatives, the Company’s ability to adequately resolve the
outstanding labeling issues with the FDA for IV meloxicam, and ,the
time frame associated with any such resolution as well as the
timeframe of any FDA action related to the IV meloxicam NDA; the
Company’s ability to raise future financing for continued product
development and IV meloxicam commercialization; with regard to the
Company’s clinical trial results, whether there may be changes in
the interpretation by the FDA of the data of the Company’s clinical
trials and the length, cost and uncertain results and timing of our
ongoing clinical trials; with regard to the potential commercial
opportunity of IV meloxicam, whether any FDA approval of IV
meloxicam will include labeling restrictions and the potential that
IV meloxicam does not receive regulatory approval or does not
receive reimbursement by third party payors, that IV meloxicam is
not accepted by the medical community, including physicians,
patients, health care providers and hospital formularies or that a
commercial market for IV meloxicam does not develop; the Company’s
ability to manage costs and execute on its operational and budget
plans; the Company’s ability to achieve its financial goals; the
Company’s ability to obtain, maintain and successfully enforce
adequate patent and other intellectual property protection; the
Company’s lack of operating history as a standalone business; risks
relating to the separation from Recro, including, among others,
failure to achieve the anticipated benefits from the separation,
reliance on Recro and other third parties to provide certain
services post-separation, and the Company’s ability to satisfy
liabilities and potential indemnification obligations in connection
with the separation. 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 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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