Recro Pharma Completes Enrollment in Phase III Safety Study of IV Meloxicam
February 27 2017 - 7:00AM
Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty
pharmaceutical company focused on products for hospital and other
acute care settings, currently developing non-opioid products for
the treatment of serious acute pain, today announced completion of
enrollment for its double-blind Phase III safety study evaluating
the safety and tolerability of intravenous (IV) meloxicam (N1539)
following major surgery.
In this multicenter, randomized, double-blind,
placebo-controlled clinical trial, over 700 patients were enrolled
and randomly assigned to receive a postoperative regimen of IV
meloxicam (30mg bolus injection) or placebo in a 3:1 ratio, once
every 24 hours for up to 7 doses following a variety of major
elective surgical procedures, including total hip and knee
replacements, hernia repair, and spinal, colorectal, and other
major surgeries.
“This is an important milestone in the clinical
development of IV meloxicam, and marks the completion of enrollment
in the third Phase III trial in Recro’s lead development program,”
said Gerri Henwood, Recro Pharma’s President and Chief Executive
Officer. “We continue to plan to file a New Drug Application (NDA)
filing in the summer of 2017.”
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
NanoCrystal® platform, a technology that enables enhanced
bioavailability of poorly water-soluble drug compounds.
About Recro Pharma, Inc.
Recro Pharma is a revenue generating specialty
pharmaceutical company focused on products for hospital and other
acute care settings that is 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 post-operative
pain, which has completed four successful Phase II clinical trials
in post-operative pain conditions and two pivotal Phase III
efficacy trials and today has reported completion of enrollment in
its remaining Phase III study. 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 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 injectable meloxicam; unfavorable
new clinical data and additional analyses of existing clinical
data; 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;
the Company’s ability to raise future financing for continued
development and payment of milestones; 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 injectable
meloxicam 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/Natalie Wildenradt
(212) 600-1902
susan@argotpartners.com
natalie@argotpartners.com
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