IV Meloxicam 30mg Demonstrates Statistically
Significant Reductions in Opioid Consumption in Overall Study
Population and Important Subpopulations, Including in Patients
Following Major Orthopedic Surgery and Advanced Age, Renally
Impaired Patients
Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty
pharmaceutical company focused on therapeutics for hospital and
other acute care settings, today announced three poster
presentations at PAINWeek 2017, taking place September 5-9, 2017,
in Las Vegas, NV. The poster presentations report safety and
opioid use data from the Company’s recently completed Phase III
safety study evaluating intravenous (IV) meloxicam 30mg following
major surgery, and reflect important acute, postoperative pain
subpopulations, including patients who underwent major orthopedic
surgeries and advanced age patients with impaired renal function.
“The clinical data being presented at PAINWeek
this year continue to demonstrate that IV meloxicam 30mg has a
favorable safety and tolerability profile, including in a
subpopulation of patients over age 65 with renal impairment who are
at an increased risk of complications and toxicities associated
with NSAID use,” said Stewart McCallum, M.D., F.A.C.S., Chief
Medical Officer of Recro Pharma. “Importantly, IV meloxicam 30mg
also demonstrated statistically significant reductions in opioid
consumption resulting in a 22-34% reduction in the overall study
population, a 31-57% reduction in the subpopulation of patients
over age 65 with renal impairment, and a 26-38% reduction in
patients undergoing major orthopedic surgeries, a very common group
of procedures where patients experience moderate to severe
postoperative pain lasting multiple days following surgery.
Collectively, we believe these Phase III results demonstrate the
differentiated safety profile and significant potential of IV
meloxicam 30mg as a new non-opioid treatment option for acute,
postoperative pain.”
IV meloxicam 30mg has successfully completed
three Phase III trials, including two Phase III efficacy trials and
one Phase III safety trial. The results from these studies,
as well as results from four Phase II trials and other safety
studies, comprised the NDA package for IV meloxicam 30mg submitted
to the U.S. Food and Drug Administration in July 2017.
Details for the poster presentations at
PAINWeek:
All posters will be on display in Condesa
Commons on Level 2 of the Cosmopolitan of Las Vegas from 3:30 pm PT
on Wednesday, September 6 through 4:30 pm PT on Friday, September
8.
Title: Safety and Opioid Use
Following Major Orthopedic Surgery in a Phase 3, Placebo-Controlled
Study of Intravenous MeloxicamPoster #:
77Summary: This poster reports study findings
within the population of patients (n=379) who underwent major
orthopedic surgeries, including joint replacements, complex foot,
bunionectomy, spinal, and other procedures. These patients
were randomized (3:1) and administered IV meloxicam 30mg (n=283) or
placebo (n=96) via IV push over 15-30 seconds every 24 hours for up
to 7 doses. Subjects could continue to receive opioid
analgesia according to the practice of the investigator to treat
uncontrolled pain symptoms; additional NSAIDs were prohibited
during inpatient treatment. The majority of subjects
(>85%) received 2 or 3 doses of study drug. In this
orthopedic patient population, IV meloxicam 30mg was well tolerated
with no deaths, and a low incidence of SAEs (2.5% of IV meloxicam
vs. 4.2% of placebo) and withdrawals due to an AE (0.4% of IV
meloxicam vs. 0% of placebo). AEs were generally mild or
moderate in intensity, and similar between treatments. The
most common treatment-emergent AEs included nausea, constipation,
vomiting, increased gamma-glutamyltransferase, headache, anaemia,
insomnia, hypotension and pruritis. Importantly, mean opioid
consumption was lower for IV meloxicam 30mg compared with placebo
at all evaluated intervals, reaching statistical significance
(p<0.05) in the Hour 0-24, Hour 24-48, Hour 48-72, and Hour 0-72
intervals with 27.4%, 26.1%, 38.4%, and 25.8% reductions in opioid
use, respectively. A lower incidence of nausea and vomiting
was observed in the IV meloxicam 30mg arm, which may have been
related to the reduction in opioid use compared with placebo.
Title: Safety and Opioid Use in
a Phase 3, Placebo-Controlled Study of Intravenous Meloxicam
Following Major SurgeryPoster #:
78Summary: This poster reports study findings from
the overall Phase 3 safety study population (n=721).
Following various major elective surgeries, including orthopedic,
abdominal, gynecologic, spinal, and other procedures, patients were
randomized (3:1) and administered IV meloxicam 30mg (n=538) or
placebo (n=183) via IV push over 15-30 seconds every 24 hours for
up to 7 doses. Subjects could continue to receive opioid
analgesia according to the practice of the investigator to treat
uncontrolled pain symptoms; additional NSAIDs were prohibited
during inpatient treatment. The majority of subjects
(>80%) received 2 or 3 doses of study drug during their
inpatient stay. In the overall study population, IV meloxicam
30mg was well tolerated with no deaths, and a low incidence of SAEs
(2.6% of IV meloxicam vs. 5.5% of placebo) and withdrawals due to
an AE (0.4% of IV meloxicam vs. 0% of placebo). AEs were
generally mild or moderate in intensity, and similar in incidence
between treatments. The most common treatment-emergent AEs
included nausea, constipation, vomiting, headache, pruritus,
increased gamma-glutamyltransferase, dizziness, and anemia.
Importantly, mean opioid consumption was numerically lower in the
IV meloxicam 30mg group compared with placebo at all evaluated
intervals, reaching statistical significance (p<0.05) in the
Hour 0-24, Hour 24-48, Hour 48-72 and Hour 0-72 intervals with
22.0%, 23.9%, 33.9 and 23.2% reductions in opioid use,
respectively. There was a lower rate of nausea and vomiting
observed in the IV meloxicam 30mg arm, which may have been related
to the reduction in opioid use compared with placebo.
Title: Safety and Opioid Use in
Subjects of Advanced Age with Impaired Renal Function in a Phase 3,
Placebo-Controlled Study of Intravenous Meloxicam Following Major
SurgeryPoster #: 79Summary: This
poster reports study findings within the population of patients
(n=119) of advanced age (66 to 80 years, with a mean age of 70.5
years) with impaired renal function (Glomerular Filtration Rate
≤89 mL/min/1.73 m2). These patients were randomized
(3:1) and administered IV meloxicam 30mg (n=88) or placebo (n=31)
via IV push over 15-30 seconds every 24 hours for up to 7
doses. Subjects could continue to receive opioid analgesia
according to the practice of the investigator to treat uncontrolled
pain symptoms; additional NSAIDs were prohibited during inpatient
treatment. The majority of subjects (>80%) received 2 or 3
doses of study drug during their inpatient stay. In this high
risk patient population, IV meloxicam 30mg was well tolerated, with
no deaths or discontinuations due to adverse events (AEs), and a
low incidence of SAEs (2.3% of IV meloxicam vs. 12.9% of
placebo). AEs were generally mild or moderate in intensity,
and similar between treatments. The most common
treatment-emergent AEs included nausea, constipation, vomiting,
anaemia, pruritus, increased gamma-glutamyltransferase, insomnia
and urinary retention. Importantly, mean opioid consumption
was numerically lower in the IV meloxicam 30mg group compared with
placebo at all evaluated intervals, reaching statistical
significance (p<0.05) in the Hour 0-24, Hour 24-48, Hour
48-72, and Hour 0-72 intervals with 30.5%, 41.9%, 56.9%, and 33.8%
reductions in opioid use, respectively.
The official PAINWeek poster reception will be
held at Condesa Commons on Level 2 on Thursday, September 7, from
6:30 – 8:30 pm PT. A Recro Pharma sponsored poster reception
will also be held at the same time near the Recro Pharma
posters.
Downloadable copies of the posters can be
accessed by visiting the “Investors” section of the Recro Pharma
website and by clicking “Presentations.”
For more information on PAINWeek, visit:
https://www.painweek.org/
More About the Phase III Safety
Study
The multicenter, randomized, double-blind,
placebo-controlled Phase III clinical trial (NCT02720692),
enrolling patients who had undergone major elective surgical
procedures, which were expected to result in hospitalization for at
least 24-48 hours, was designed to evaluate the safety and
tolerability of IV meloxicam 30mg in patients following major
elective surgery. 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. 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 IV meloxicam 30mg or IV placebo daily for
up to 7 doses. A total of 721 patients received at least one
dose of study medication.
About IV/IM Meloxicam 30mg
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 30mg 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 at the
Company’s Gainesville facility. 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 30mg has
successfully completed two pivotal Phase III clinical efficacy
trials in patients following bunionectomy and abdominoplasty
surgeries, a large double blind Phase III safety trial, four Phase
II clinical trials for the management of moderate to severe
post-operative pain, as well as other safety studies. As
injectable meloxicam is in the non-opioid class of drugs, 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: the ability to
obtain and maintain regulatory approval of injectable meloxicam
and, and the labeling under any such approval; regulatory
developments in the United States and foreign countries; results
and timing of the clinical trials of injectable meloxicam, the
Company’s ability to achieve its financial goals, including
financial guidance; the Company’s ability to raise future financing
for continued development and the payment of milestones; the
Company’s ability to pay its debt; customer product performance and
ordering patterns, the performance of third-party suppliers and
manufacturers; the Company’s ability to obtain, maintain and
successfully enforce adequate patent and other intellectual
property protection; and the successful commercialization of
injectable meloxicam. In addition, 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. Recro assumes no
obligation to update any such forward looking statements.
CONTACT:
Investor Relations Contact:
Argot Partners
Susan Kim/Natalie Wildenradt
(212) 600-1902
susan@argotpartners.com
natalie@argotpartners.com
Recro Pharma, Inc.
Michael Celano
(484) 395-2413
mcelano@recropharma.com
Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com
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