Recro Pharma Receives Complete Response Letter from the FDA
May 24 2018 - 7:00AM
Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty
pharmaceutical company focused on therapeutics for the hospital and
other acute care settings, today announced it has received a
Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA) Office of Drug Evaluation II regarding
the New Drug Application (NDA) for IV meloxicam.
The CRL stated that although the outcome of the
pivotal phase III trials demonstrated statistically significant
outcomes on the primary endpoints, the FDA is unable to approve the
application in its current form. The CRL states that data
from ad hoc analyses and selective secondary endpoints suggest that
the analgesic effect does not meet the expectations of the
FDA. In addition, the CRL raised CMC related questions on
extractable and leachable data provided in the NDA.
“We are extremely disappointed for patients and
providers who are looking for a non-opioid alternative for relief
of pain. We stand behind the body of evidence included in our
NDA and are committed to further discussions with FDA in order to
bring this important medicine to patients. We intend to
request a meeting with the FDA as soon as possible to discuss the
points raised in the CRL and look forward to working with the
Agency to find solutions that can contribute to solving the current
opioid public healthcare problem,” said Gerri Henwood, President
and Chief Executive Officer of Recro.
Conference Call and Webcast
Recro Pharma management will be hosting a
conference call and webcast today beginning at 8:00 a.m. ET. To
access the conference call, please dial (844) 243-4691 (local) or
(225) 283-0379 (international) at least 10 minutes prior to the
start time and refer to conference ID 9385399. A webcast will be
available in the investor relations section of the Company's
website, www.recropharma.com. A live audio webcast of the call will
be available under "Events" in the Investor section of the
Company's website, https://ir.recropharma.com/events. An archived
webcast will be available on the Company's website approximately
two hours after the event and will be available for 60 days.
About Recro Pharma, Inc.
Recro Pharma is a specialty pharmaceutical
company that operates through two business divisions, an Acute
Care, hospital product division and a revenue-generating contract
development and manufacturing, or CDMO division, located in
Gainesville, GA. The Acute Care division is primarily focused on
developing innovative products for hospital and other acute care
settings. The Company’s lead product candidate is a proprietary
injectable form of meloxicam, a 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. As injectable
meloxicam is in the non-opioid class of drugs, if approved, the
Company believes it will 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. The Company’s CDMO division
leverages its formulation expertise to develop and manufacture
pharmaceutical products using its proprietary delivery technologies
and other manufacturing services for commercial partners who
commercialize or plan to commercialize these products. These
collaborations can result in revenue streams including royalties,
profit sharing, research and development and manufacturing fees,
which support continued operations for its CDMO division and it
contributes non-dilutive funding for the development and
pre-commercialization activities of its Acute Care division.
Cautionary Statement Regarding Forward Looking
Statements
This press release contains forward-looking
statements that involve risks and uncertainties. Such
forward-looking statements reflect Recro's expectations about its
future performance and opportunities that involve substantial risks
and uncertainties. When used herein, the words "anticipate,"
"believe," "estimate," "upcoming," "plan," "target," "intend" and
"expect" and similar expressions, as they relate to Recro or its
management, are intended to identify such forward-looking
statements. These forward-looking statements are based on
information available to Recro as of the date of this press release
and are subject to a number of risks, uncertainties, and other
factors that could cause Recro’s performance to differ materially
from those expressed in, or implied by, these forward-looking
statements. Recro assumes no obligation to update any such
forward-looking statements. Factors that could cause Recro’s actual
performance to materially differ from those expressed in the
forward-looking statements set forth in this press release include,
without limitation: our statements about our ability to adequately
and timely respond to the deficiencies in the CRL issued by the FDA
may be affected by whether any such response will be accepted by
the FDA, our ability and timing to resubmit the NDA, FDA acceptance
and approval of the resubmitted NDA, the FDA may require additional
studies to address the concerns raised in the CRL, our statements
about the results of our clinical trial could be affected by the
potential that there are changes in the interpretation of the data
by the FDA; our statements about the potential commercial
opportunity could be affected by potential labeling restrictions,
the potential that our product does not receive regulatory
approval, whether Recro can completely or timely respond to FDA’s
requests regarding CMC extractable and leachables, or that FDA may
require additional data or the time frame that may be required to
deliver such data. The forward-looking statements in this
press release should be considered together with the risks and
uncertainties that may affect Recro’s business and future results
included in Recro’s filings with the Securities and Exchange
Commission at www.sec.gov.
CONTACT:
Investor Relations Contact:Argot PartnersSusan
Kim/Natalie Wildenradt(212)
600-1902susan@argotpartners.comnatalie@argotpartners.com
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