New Meta-Analysis Data Suggests IV Meloxicam
Produces Largest SPID, Greater Reduction in Opioid Use and Better
Safety Profile Compared to Other Non-Opioid Medications for
Moderate to Severe Pain
Recro Pharma, Inc. (Nasdaq:REPH), a specialty pharmaceutical
company with a high-performing revenue generating contract
development and manufacturing (CDMO) segment, today announced a
moderated poster presentation highlighting new intravenous (IV)
meloxicam data at the 44th Annual Regional Anesthesiology and Acute
Pain Medicine Meeting, hosted by the American Society of Regional
Anesthesia and Pain Medicine, taking place April 11-13, 2019, in
Las Vegas.
The abstract was a highly scored submission, and
was selected for a five minute oral presentation. In this study,
the researchers conducted a network meta-analysis (NMA) assessing
the safety and efficacy of IV meloxicam relative to other IV
non-opioid analgesics for moderate to severe pain. The analysis was
conducted by comparing Recro Pharma’s IV meloxicam data to 17
randomized controlled clinical trials evaluating several non-opioid
analgesics, including acetaminophen, ketorolac, placebo combined
with a non-opioid and placebo combined with an opioid, across three
procedure categories: abdominal, bunionectomy and orthopedic.
A pooled analysis of pain outcomes across all
bunionectomy procedure studies and time points demonstrated a
probability of 84% that IV meloxicam produced the largest sum of
pain intensity difference (SPID). A pooled analysis of pain
outcomes across all abdominal procedure studies and time points
demonstrated a probability of 72% that IV meloxicam produced the
largest SPID. Both of these outcomes are consistent with the
Surface Under Cummulative Ranking Curve (SUCRA) rankings. IV
meloxicam could not be evaluated against other non-opioid IV
analgesics in orthopedic procedures due to a lack of reported pain
score data for IV meloxicam in orthopedic procedures. IV meloxicam
was associated with a pooled 18% reduction in morphine (milligram
equivalent) utilization (range 25% to 12%), compared to a 16%
reduction for ketorolac and a 14% reduction for acetaminophen.
For safety, IV meloxicam was associated with
lower pooled odds of gastrointestinal opioid-related adverse events
(ORADEs) (OR=0.72; 95% credible interval [Crl] 0.66-0.78) and
respiratory ORADEs (OR=0.51; 95% Crl 0.42-0.59). IV meloxicam
offered no relative benefits with respect to adverse events (AEs)
not related to opioids.
“These data show that IV meloxicam is associated
with lower pain, morphine utilization and opioid-related AEs
postoperatively across a number of important clinical comparisons,”
said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of
Recro Pharma. “We continue to believe that IV meloxicam would be an
attractive non-opioid pain management candidate for the hospital
marketplace, and we are committed to working closely with the U.S.
Food and Drug Administration to bring it to the physicians and
patients who could benefit from it.”
Details for the moderated presentation
are as follows:
Title: Network Meta-Analysis to
Evaluate Intravenous Meloxicam versus other Intravenous Non-Opioid
Medications for Moderate-Severe Postoperative PainLead
author: John Carter, MSID number: 7309;
MP-07a Date and time: Friday, April 12, 2019 from
1:45-3:15pmLocation: Cesar’s Palace – Room:
Patrician
A downloadable copy of the poster can be
accessed following conclusion of the presentation by visiting the
“Investors” section of the Recro Pharma website and clicking
“Presentations.”
For more information on this meeting, visit:
https://www.asra.com/.
About IV/IM Meloxicam
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 (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 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 the 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 and four
Phase II clinical efficacy trials, as well as other safety studies.
On March 22, 2019 Recro announced that FDA had provided a second
CRL in response to the Company’s NDA for IV meloxicam. The Company
is evaluating the path forward for IV meloxicam and plans to
schedule a meeting with the FDA. As injectable meloxicam is in the
non-opioid class of drugs, if approved, the Company believes it 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. 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 and
development-stage 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," "may," "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: the Company’s ability to
attract a strategic partner for the development and
commercialization of IV meloxicam, the Company’s ability to
adequately resolve the deficiencies identified by the FDA in the
second CRL for IV meloxicam, and the time frame associated with any
such resolution, including whether the FDA will require additional
clinical studies and the time and cost of such studies; whether the
Company will prepare an amended new drug application (NDA) for IV
meloxicam and, whether the FDA will accept and approve any such
resubmitted NDA and the labeling under any such approval; 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,
including financial guidance, the Company’s ability to pay its debt
under its credit agreement; the Company’s ability to maintain
relationships with CDMO commercial partners; and the Company’s
ability to obtain, maintain and successfully enforce adequate
patent and other intellectual property protection. 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 PartnersSam Martin / Claudia
Styslinger(212) 600-1902sam@argotpartners.com
claudia@argotpartners.com
Recro Pharma, Inc. Ryan D. Lake (484) 395-2436
rlake@recropharma.com
Media Contact: Argot Partners David Rosen (212) 600-1902
david.rosen@argotpartners.com
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