Recro Pharma Announces Publication of Phase III IV Meloxicam Bunionectomy Data in the Clinical Journal of Pain
March 27 2018 - 07:00AM
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 Phase
III clinical data for intravenous (IV) meloxicam for the treatment
of pain following bunionectomy surgery. The article, titled
”Efficacy and Safety of Intravenous Meloxicam in Subjects with
Moderate-to-Severe Pain Following Bunionectomy,” was published
online in the Clinical Journal of Pain.
“As previously reported, the data from this
Phase III trial demonstrate that IV meloxicam provides rapid and
sustained pain relief following bunionectomy surgery, a favorable
safety and tolerability profile, and a significant opioid-sparing
effect,” said Stewart McCallum, M.D., Chief Medical Officer of
Recro Pharma. “An urgent, unmet medical need for non-opioid agents
for the management of moderate to severe pain persists for patients
and physicians. The New Drug Application for IV meloxicam is
currently under review with the U.S. Food and Drug Administration
with a target PDUFA date of May 26, 2018. If approved, IV meloxicam
will be the first 24-hour duration, non-opioid, IV analgesic for
moderate to severe pain.”
The Phase III, multi-center, randomized,
double-blind, placebo-controlled trial (n=201) was designed to
evaluate the efficacy and safety of IV meloxicam 30mg for the
management of moderate to severe pain following bunionectomy
surgery. The primary efficacy endpoint was Summed Pain Intensity
Difference (SPID) over 48 hours (SPID48). IV meloxicam 30mg
achieved a statistically significant difference reduction in SPID48
(p=0.0034), as well as statistically significant reductions in SPID
values at other times and intervals (SPID6, SPID12, SPID24,
SPID24-48), among other key secondary endpoints. Additionally, an
opioid-sparing effect was observed for IV meloxicam 30mg, indicated
by a longer time to first use of rescue (p=0.0076), a lower number
of subjects using rescue (p<0.001) and the lower mean number of
per-subject rescue doses (p<0.05). IV meloxicam 30mg was well
tolerated, with no associated serious adverse events (SAEs) or
withdrawals due to adverse events (AEs). The majority of
treatment-emergent adverse events in the IV meloxicam 30mg group
were reported as mild or moderate in intensity, with incidence and
intensity comparable 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 long-acting 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. In 2017, Recro
submitted the NDA for IV meloxicam to the FDA for review, it was
accepted by the FDA and there is a late May 2018 PDUFA date. 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 Company’s ability to obtain and maintain
regulatory approval of IV meloxicam and the labeling under any such
approval; the Company’s ability to successfully launch and
commercialize IV meloxicam, if approved; results and timing of the
phase IIIb clinical trials of IV meloxicam; the extent to which IV
meloxicam, if approved, is accepted by the medical community,
including physicians, patients, health care providers and hospital
fomularies; 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 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)
600-1902 david.rosen@argotpartners.com
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