Recro Pharma Announces Publication of Supportive Phase II IV Meloxicam Bunionectomy Data in the Journal of Pain Research
February 20 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 II clinical data for intravenous (IV)
meloxicam for the treatment of pain following bunionectomy surgery.
The article, titled “Evaluation of the safety and efficacy of an
intravenous nanocrystal formulation of meloxicam in the management
of moderate-to-severe pain after bunionectomy,” was published
online in the Journal of Pain Research.
“Moderate to severe pain is common following
bunionectomy, particularly in the first few days after surgery,”
said Stewart McCallum, MD, Chief Medical Officer of Recro Pharma.
“Selection of effective pain control strategies for these patients
is generally guided by the intensity of the pain, the duration of
analgesia provided and the associated risks and benefits of the
particular therapy. Although opioids have traditionally been the
mainstay of postoperative pain management, opioid related adverse
events, together with the possibility of long-term dependence, have
created a need for effective non-opioid analgesics. The data from
this Phase 2 study support the growing body of clinical evidence
demonstrating that IV meloxicam acts rapidly and offers durable
pain relief, with a favorable safety profile. We believe IV
meloxicam 30mg, for which we are awaiting a May 2018 approval
decision from the U.S. Food and Drug Administration, has the
potential to play a meaningfully differentiated role in the
management of moderate to severe, postoperative pain.”
The randomized, double-blind, placebo-controlled
study (n=59) was designed to evaluate the safety and efficacy of
two intravenously-administered doses of IV meloxicam (30mg and
60mg) versus placebo in subjects with moderate-to-severe pain
following a standardized unilateral bunionectomy. The primary
efficacy endpoint was effect size based on the difference in Summed
Pain Intensity Differences over the first 48 hours (SPID48). Both
doses of IV meloxicam produced meaningful effect sizes compared to
placebo, and both doses of IV meloxicam demonstrated statistically
significant reductions in pain compared to placebo at all evaluated
times and intervals. Additionally, IV meloxicam demonstrated a
favorable safety and tolerability profile, with no reported serious
adverse events or withdrawals due to adverse events, including
injection-related adverse events.
The full publication, including a video
presentation of this abstract, narrated by Ira J. Gottlieb, DPM,
principal investigator of the study and lead author of the paper,
can be accessed here.
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
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, product commercialization 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. 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 PartnersSusan
Kim/Natalie Wildenradt(212)
600-1902susan@argotpartners.comnatalie@argotpartners.com
Recro Pharma, Inc.Michael Celano(484)
395-2413mcelano@recropharma.com
Media Contact:Argot PartnersDavid Rosen(212)
600-1902david.rosen@argotpartners.com
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