Recro Pharma Presents Clinical Data at PAINWeek 2016
September 07 2016 - 4:05PM
Recro Pharma, Inc. (“Recro” or the “Company”) (Nasdaq:REPH), a
revenue generating specialty pharmaceutical company focused on
products for hospital and ambulatory care settings, currently
developing non-opioid products for the treatment of serious acute
pain, today announced a poster presentation at this year’s
PAINWeek®, the National Conference on Pain for Frontline
Practitioners, taking place in Las Vegas, NV from September 6 – 10,
2016. The poster presentation highlights data from a clinical trial
evaluating the efficacy and safety of intravenous (IV) meloxicam
(N1539) in subjects with moderate to severe pain following
bunionectomy from a phase II study.
The poster will be available for viewing at the
Gracia 7 section at the Cosmopolitan of Las Vegas during the
meeting. Company representatives will be available to discuss the
poster during an author-attended session on Thursday, September 8,
from 6:30 pm – 8:30 pm PDT.
“In the results presented at this year’s
PAINWeek meeting, IV meloxicam was shown to demonstrate a
significant reduction in post-operative pain reduction following
bunionectomy surgery, a highly relevant pain model, with a
favorable tolerability profile,” said Stewart McCallum, MD, Recro
Pharma’s Chief Medical Officer. “These phase II results validate
Recro Pharma’s ongoing Phase III clinical program and highlight IV
meloxicam’s therapeutic potential as a promising non-opioid option
for patients with acute postoperative pain.”
These data are being presented in support of the
Company’s lead product, IV meloxicam, a proprietary, preferential,
long-acting COX-2 inhibitor that has successfully completed the
first of three pivotal Phase III trials, examining efficacy
following bunionectomy surgery, as well as multiple Phase II
trials.
Details for the poster presentation at PAINWeek
are as follows:
Title: An Evaluation of the
Safety and Efficacy of N1539, a Novel Intravenous Formulation of
NanoCrystalMeloxicam, Administered By IV Push in Subjects with
Moderate to Severe Pain Following BunionectomyPoster
Number: 83Summary: The poster describes
the phase II, single-center, randomized, double-blind,
placebo-controlled study in male and female subjects, age 18-75
years in otherwise good health, undergoing simple unilateral
bunionectomy. The primary efficacy objective was to evaluate the
effect size of N1539 using the summed PI difference from Hour 0 to
48 (SPID48) after dosing. This phase II study supports the safety
and tolerability of N1539 at a 60 or 30 mg IV dose administered
once daily as a bolus over 15-30 seconds. Additionally, the study
demonstrated superior efficacy of N1539 at 60 and 30 mg dose levels
versus placebo at all evaluated SPID intervals (6, 12, 24, 48,
12-48, and 24-48 hours). The efficacy analysis was favorable for
both N1539 dose levels compared to placebo with estimated effect
size ranging from 0.52 to 1.01 per observed SPID48, and
statistically significant differences in SPID intervals throughout
the study. As no incremental benefit was identified using a
higher treatment dose, this study supports the use of N1539 30 mg
administered IV once daily in post-operative settings where
patients are expected to have moderate to severe pain.
A downloadable copy of the poster can be
accessed by visiting the “Investors” section of the Recro Pharma
website and by clicking “Presentations.”
About Recro Pharma, Inc.
Recro Pharma is a revenue generating specialty
pharmaceutical company focused on products for hospital and
ambulatory care settings, currently developing non-opioid products
for the treatment of serious acute pain. Recro Pharma is currently
developing IV meloxicam, a proprietary, long-acting preferential
COX-2 inhibitor for treatment of acute postoperative pain, which
has completed four successful Phase II clinical trials in
postoperative pain conditions and has reported positive results
from its first pivotal Phase III clinical trial in patients
following bunionectomy surgery. An additional development
candidate, Dex-IN, a proprietary intranasal formulation of
dexmedetomidine, is being pursued for the treatment of
peri-procedural pain, and has had a past successful Phase II trial
in bunionectomy. As Recro Pharma’s product candidates are not in
the opioid class of drugs, the Company believes its candidates
would avoid many of the side effects associated with commonly
prescribed opioid therapeutics, such as addiction, constipation and
respiratory distress, while maintaining analgesic effect.
Recro Pharma also owns and operates a 97,000
square foot, DEA-licensed facility that manufactures five
commercial products and receives manufacturing revenues and
royalties associated with the sales of these products.
Cautionary Statement Regarding Forward
Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
Company’s strategy, future operations, clinical development plans
and other statements containing the words "anticipate," "believe,"
"estimate," "upcoming," "plan," "target," "intend," "expect" and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: results and timing of the clinical trials of IV
meloxicam and Dex-IN; unfavorable new clinical data and additional
analyses of existing clinical data; whether results of early
clinical trials will be indicative of the results of future trials
and whether interim results from a clinical trial will be
predictive of the final results of the trial; the ability to obtain
and maintain regulatory approval of IV meloxicam and Dex-IN, and
the labeling under any such approval; regulatory developments in
the United States and foreign countries; the Company’s ability to
raise future financing for continued development; the Company’s
ability to pay its debt; 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; the successful commercialization of
IV meloxicam and Dex-IN and other factors discussed in the
Risk Factors set forth in the Company’s Annual Report on Form 10-K
and Quarterly Reports on Form 10-Q filed with the Securities and
Exchange Commission (SEC) and in other filings the Company makes
with the SEC from time to time. In addition, the forward-looking
statements included in this press release represent the Company’s
views only as of the date of this press release. Important factors
could cause our actual results to differ materially from those
indicated or implied by forward-looking statements, and as such we
anticipate that subsequent events and developments will cause our
views to change. However, while we may elect to update these
forward-looking statements at some point in the future, we
specifically disclaim any obligation to do so. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
CONTACT:
Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com
Investor Relations Contact:
Argot Partners
Susan Kim
(212) 600-1902
susan@argotpartners.com
Recro Pharma (NASDAQ:REPH)
Historical Stock Chart
From Mar 2024 to Apr 2024
Recro Pharma (NASDAQ:REPH)
Historical Stock Chart
From Apr 2023 to Apr 2024