Recro Pharma, Inc. (NASDAQ:REPH), a revenue generating specialty
pharmaceutical company focused on therapeutics for the
hospital and other acute care settings, today announced a poster
presentation highlighting intravenous (IV) meloxicam’s effect on
platelet function at the 72nd PostGraduate Assembly in
Anesthesiology (PGA72), sponsored by the New York State Society of
Anesthesiologists (NYSSA), taking place December 7-11, 2018, in New
York City.
The poster, titled “An Ex-vivo Assessment of the
Effects of Meloxicam IV on Platelet Function,” which was presented
by lead author Jonathan S. Jahr, M.D., David Geffen School of
Medicine at UCLA, describes results from an ex vivo study assessing
the effects of various concentrations of IV meloxicam (5mcg/mL,
10mcg/mL, 15mcg/mL and 20mcg/mL) on platelet function compared to
ketorolac (2.5mcg/mL and 5mcg/mL) and an untreated control.
The 5mcg/mL concentration of IV meloxicam in this study corresponds
to the maximum plasma levels following a 30mg dose in the clinical
setting. Similarly, the 5mcg/mL concentration of ketorolac in
this study corresponds to a 30mg and the 2.5mcg/mL dose corresponds
to the 15mg dose in the clinical setting. In this study,
blood samples provided by healthy volunteers (n=8) were analyzed to
determine closure time (CT) following the addition of IV meloxicam
and ketorolac at the previously mentioned concentrations to the
blood plasma samples. The researchers conducted the analyses
using a platelet function analyzer (PFA-100), a standard of care
for platelet function testing, and two different reagents, collagen
with epinephrine (CEPI) and collagen with adenosine diphosphate
(CADP).
In the CEPI reagent analysis, a significant
treatment effect was observed for changes in CT (p=0.0441).
No significant difference was observed in CT for the IV meloxicam
treated samples versus the untreated control at any of the
evaluated concentrations (p≥0.5400). When compared to
untreated control, the ketorolac treated sample CT values were
significantly prolonged in both the 2.5mcg/mL and the 5mcg/mL
concentrations (p≤0.0257). All IV meloxicam concentration
levels had a significantly shorter CT compared to the 2.5mcg/mL
ketorolac concentration (p<0.005). All IV meloxicam
concentration levels had numerically shorter CTs compared to the
5mcg/mL ketorolac concentration, though only the 10mcg/mL IV
meloxicam concentration reached statistical significance. In
the CADP reagent analysis, neither IV meloxicam nor ketorolac
demonstrated a significant change in CT versus untreated control
(p≥0.0907).
“A concern around the use of non-steroidal
anti-inflammatory drugs (NSAIDs) in the peri- or post-operative
setting is the potential for platelet dysfunction and risk of
bleeding related events,” commented Dr. Jahr. “Our thesis
here was that IV meloxicam’s higher affinity for COX-2 inhibition,
versus COX-1, would translate into a lower risk for platelet
dysfunction. The data presented this year at PGA72 show that
IV meloxicam achieved roughly the same closure times (CTs) as
untreated controls and numerically shorter CTs than
ketorolac. In contrast, significant CT prolongations were
observed in ketorolac samples compared with untreated
control. These results suggest that IV meloxicam has the
potential to provide a meaningful clinical benefit over ketorolac
with respect to a decreased risk of platelet dysfunction.”
“NSAIDs are an integral part of the analgesic
toolkit and are the physician’s first-line defense to prevent or
treat pain,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical
Officer of Recro Pharma and co-author of the poster. “These
compelling data continue to build upon the growing body of data
supporting IV meloxicam’s safety and reinforce the positive safety
findings elucidated by our comprehensive IV meloxicam development
program. The IV meloxicam New Drug Application is currently
under review by the U.S. Food and Drug Administration and we are
currently awaiting our PDUFA goal date of March 24, 2019.”
A downloadable copy of the poster can be
accessed by visiting the “Investors” section of the Recro Pharma
website and clicking “Presentations.”
For more information on PGA72,
visit: http://www.pga.nyc/.
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 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. Recro’s Complete
Response to the CRL for IV meloxicam was accepted for filing by the
FDA in early October 2018 and assigned a PDUFA date of March 24,
2019. 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," "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 resolve the
deficiencies identified by the FDA in the CRL for IV meloxicam;
whether the FDA will approve the Company’s amended NDA for IV
meloxicam and, if approved, the labeling under any such approval;
if the FDA does not approve the Company’s amended NDA, the time
frame otherwise associated with resolving the deficiencies
identified by the FDA in the CRL and whether the FDA will require
additional clinical studies to support the approval of IV meloxicam
and the time and cost of such studies; the Company’s ability to
successfully launch and commercialize IV meloxicam, if approved;
the length, cost and uncertain results and timing of the Company’s
clinical trials, including the Company’s Phase IIIb clinical trials
and any additional clinical trials that the FDA may require in
connection with IV meloxicam; the extent to which IV meloxicam, if
approved, is accepted by the medical community, including
physicians, patients, health care providers and hospital
formularies; the availability of coverage and adequate and timely
reimbursement for IV meloxicam, if approved; the Company’s ability
to raise future financing for continued product development, IV
meloxicam commercialization and the payment of milestones; the
Company’s ability to achieve its financial goals, including
financial guidance; the Company’s ability to pay its debt;
regulatory developments in the United States and foreign countries;
customer product performance and ordering patterns, the performance
of third-party suppliers and manufacturers; and the Company’s
ability to obtain, maintain and successfully enforce adequate
patent and other intellectual property protection. In particular,
there can be no assurance that the FDA will complete its review by
the PDUFA goal date, that the FDA will not require changes or
additional data with respect to the amended NDA or that the FDA
will approve the amended NDA. 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 PartnersNatalie Wildenradt /
Claudia Styslinger(212) 600-1902natalie@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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