Recro Pharma Announces Publication of Phase III IV Meloxicam Abdominoplasty Data in Plastic and Reconstructive Surgery Global...
June 26 2018 - 7:00AM
Recro Pharma, Inc. (NASDAQ:REPH), a revenue generating specialty
pharmaceutical company focused on therapeutics for the hospital and
other acute care settings, today announced the publication of
previously reported Phase III clinical data for intravenous (IV)
meloxicam for the treatment of pain following abdominoplasty
surgery. The article, titled “Efficacy and Safety of Intravenous
Meloxicam in Subjects with Moderate to Severe Pain Following
Abdominoplasty,” was published online in the Plastic and
Reconstructive Surgery Global Open (PRS Global Open).
“The results of Recro’s Phase III trial
evaluating IV meloxicam for the treatment of pain following
abdominoplasty surgery detailed in this article demonstrate the
efficacy and favorable safety profile of IV meloxicam,” said
Stewart McCallum, M.D., Chief Medical Officer of Recro Pharma. “As
a long-acting, non-opioid option, IV meloxicam’s differentiated
profile has the potential to become a valuable alternative for
patients and physicians in the management of moderate to severe
pain.”
The Phase III, multi-center, randomized,
double-blind, placebo-controlled trial (n=219) was designed to
evaluate the efficacy and safety of IV meloxicam 30mg for the
management of moderate to severe pain following abdominoplasty
surgery. The primary efficacy endpoint was Summed Pain Intensity
Difference (SPID) over 24 hours (SPID24). IV meloxicam 30mg
achieved a statistically significant difference in SPID24
(p=0.0145) as compared to placebo, as well as statistically
significant differences over placebo in SPID values at other times
and intervals (SPID12, SPID48, SPID24-48), among other key
secondary endpoints. Additionally, IV meloxicam 30mg was associated
with a reduction in the number of subjects receiving opioid rescue
medication during hours 24 to 48 and the total number of doses of
opioid rescue analgesia. IV meloxicam 30mg was well tolerated, with
the numbers and frequencies of adverse events similar to
placebo.
The full publication can be accessed here.
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 once a day 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. As injectable
meloxicam is in the non-opioid class of drugs, if approved, 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 Company’s
ability to resolve the deficiencies identified by the FDA in the
complete response letter for IV meloxicam and the time frame
associated with such resolution, including whether the FDA will
require additional clinical studies and the time and cost of such
studies; whether the Company will be able to prepare an amended new
drug application (NDA) for IV meloxicam and, if prepared, whether
the FDA will accept and approve the NDA and the labeling under any
such approval; 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. 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 Partners Natalie Wildenradt
(212) 600-1902 natalie@argotpartners.com
Recro Pharma, Inc. Ryan Lake (484) 395-2436
rlake@recropharma.com
Media Contact: Argot Partners David Rosen (212) 600-1902
david.rosen@argotpartners.com
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