Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty
pharmaceutical company focused on therapeutics for hospital and
other acute care settings, today announced the presentation of
clinical data from its Phase III study evaluating intravenous (IV)
meloxicam 30mg for the treatment of acute postoperative pain in
patients following bunionectomy surgery, at the American Pain
Society 36th Annual Scientific Meeting, taking place May 17-20,
2017, in Pittsburgh, PA. The poster presentation highlights
the clinical performance of IV meloxicam 30mg, including
achievement of the study’s primary endpoint, a statistically
significant difference in Summed Pain Intensity Difference (SPID)
over the first 48 hours (SPID48) compared to placebo, along with
detailed secondary endpoints and safety results.
“The detailed Phase III results presented at the
American Pain Society annual meeting highlight the clinical
performance of IV meloxicam 30mg and the key features it can offer
clinicians who are seeking non-opioid pain relief alternatives for
their patients recovering from surgery,” said Stewart McCallum,
M.D., F.A.C.S., Chief Medical Officer for Recro Pharma and
co-author of the poster. “The data from this late-stage trial
demonstrate that IV meloxicam 30mg provides rapid and sustained
pain relief following bunionectomy surgery, a favorable safety and
tolerability profile, and statistically significant differences in
rescue use and numerous other pain relief metrics, including length
of time to opioid rescue and number of patients utilizing opioid
rescue analgesia, among others.”
Gerri Henwood, President and Chief Executive
Officer of Recro, commented, “These exciting data demonstrate the
key clinical attributes of IV meloxicam 30mg and support its
potential as a new, non-opioid pain treatment option. If
approved, IV meloxicam will be the only intravenously administered,
once-daily, non opioid pain product and we believe it will play a
meaningful role in the physician’s analgesic toolkit. The
data from this pivotal clinical trial in bunionectomy, together
with the positive results from our Phase III trial in patients
following abdominoplasty surgery and the positive Phase III safety
trial results reported last week, will form the basis of a New Drug
Application (NDA) for IV meloxicam 30mg for the treatment of
moderate-to-severe pain, which we plan to file with the U.S. Food
and Drug Administration during early third quarter 2017.”
Efficacy Results
In this multicenter, randomized, double-blind,
placebo-controlled clinical trial, 201 patients were enrolled and
randomly assigned to receive a postoperative regimen of IV
meloxicam 30mg (bolus injection) or placebo in a 1:1 ratio, once
every 24 hours for up to 3 doses following bunionectomy surgery, a
representative hard tissue surgery. For the study’s primary
endpoint, there was a statistically significant difference in
SPID48 favoring IV meloxicam 30mg over placebo (p=0.0034).
The study also achieved statistical significance
for 15 secondary endpoints. IV meloxicam 30mg demonstrated
statistically significant differences in SPID6 (p=0.0153), SPID12
(p=0.0053), SPID24 (p=0.0084), SPID24-48 (p=0.0050).
Statistically significant differences favoring IV meloxicam 30mg
over placebo were also achieved for time to first use of rescue
analgesia (p=0.0076), number of patients utilizing rescue analgesia
at certain intervals (Hour 0-24, Hour 24-48, Hour 0-48), and number
of rescue doses utilized per patient at certain intervals (Hour
0-24, Hour 24-48, Hour 0-48). The proportion of subjects
reporting good or better (2+) pain control on the Patient Global
Assessment (PGA) was significantly higher for IV meloxicam 30 mg
compared to placebo at Hour 24 (57.9% vs. 43.3%; p=0.0452) and Hour
48 (84.2% vs. 65.6%; p=0.0043). The IV meloxicam 30 mg
treatment group had a statistically significantly greater number of
subjects experiencing ≥ 30% improvement at Hour 6 (p=0.0451) and
Hour 24 (p=0.0107), and ≥ 50% improvement at Hour 24 (p=0.0430)
compared to placebo.
Safety Results
Doses of IV meloxicam 30mg were well tolerated
during the study, with the majority of subjects receiving 3 study
doses (73%). Adverse events (AEs) were generally reported to
be of mild intensity and occurred with greatest overall frequency
in the placebo group. No deaths, serious adverse events
(SAEs) or discontinuations due to an AE occurred in the IV
meloxicam 30mg group. Two SAEs were reported in the placebo
group; fracture of the bunionectomy repair secondary to trauma, and
sudden death. AEs of special interest (including hepatic,
renal, cardiovascular, bleeding, wound healing, and injection site
events) were infrequent, with a greater incidence overall in the
placebo group. There was no apparent trend in clinically
meaningful abnormal laboratory results between the treatment
groups. No trends for changes in vital signs or ECGs were
observed.
A downloadable copy of the poster can be
accessed by visiting the “Investors” section of the Recro Pharma
website and by clicking “Presentations.”
Details for the poster presentation at
APS 2017:
Title: Efficacy and Safety of
N1539, Intravenous Meloxicam, in a Phase 3 Study of Subjects with
Moderate to Severe Pain following
BunionectomyPresenter: Richard Pollak, D.P.M.,
M.S., Endeavor Clinical TrialsPoster Board #:
391Session: Phase I-III Clinical Trials and
Pediatric Clinical TrialsLocation: Convention
Center, Halls A-C, Poster Section 33Date and Time:
Wednesday, May 17, 2017 at 4:15pm ET through Friday, May 19, 2017
at 1:30pm ET
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 a
NanoCrystal® platform, a technology that enables enhanced
bioavailability of poorly water-soluble drug compounds.
About Recro Pharma, Inc.
Recro 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 has successfully completed four Phase
II clinical trials in the management of moderate to severe
post-operative pain and two pivotal Phase III clinical efficacy
trials in patients following bunionectomy and abdominoplasty
surgeries, as well as a large double blind Phase III safety trial
and 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 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: results and timing
of the clinical trials of injectable meloxicam, the preparation and
filing of other portions of the drug application, including CMC,
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;
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:
Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com
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
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