Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty
pharmaceutical company focused on therapeutics for hospital and
other acute care settings, today announced eight poster
presentations at the 43rd Annual Regional Anesthesiology and Acute
Pain Medicine Meeting which is being held simultaneously with the
2018 World Congress on Regional Anesthesia & Pain
Medicine. The meeting is co-hosted by the American Society of
Regional Anesthesia and Pain Medicine (ASRA) and is taking place
April 19-21, 2018, in New York City.
“This previously reported data contributes to
the broad body of evidence supporting IV meloxicam as a treatment
for the management of moderate to severe pain,” said Stewart
McCallum, M.D., Chief Medical Officer of Recro Pharma. “IV
meloxicam has consistently demonstrated the ability to provide
durable pain relief, alongside a favorable safety and tolerability
profile, in a range of clinical studies, and we continue to look
forward to the May 26, 2018 PDUFA date, a critical step in
providing physicians and patients with a novel, non-opioid
treatment option.”
Recro Pharma will also be hosting an industry
‘Lunch and Learn’ session at the meeting titled, “Challenges in
Acute Postsurgical Pain and Advances in the Approach to
Management”. The session will take place on Friday, April 20, 12:00
to 12:45 pm ET, in Broadway North. Lunch will be
provided.
The event will feature presentations by medical
experts in the field of pain management, including:
Director,
Acute Pain Management, Thomas Jefferson
University
Director,
Pain Management and Palliative Care, Englewood Hospital and Medical
Center
Anesthesiology Specialist,
Cleveland Clinic
- Tong Joo Gan, MD, MSH, FRCA, MBA
Professor and Chairman, Department of
Anesthesiology, Stony Brook School of Medicine
Details for the Recro data poster
presentations are as follows:
Title: A Summary of Safety,
Efficacy, and Dose Ranging in Phase 2 Clinical Studies of Meloxicam
IVPoster #: 5097Date and Time:
April 19, 2018 at 8:00-9:45 am ETLocation: Uris
(Shubert Complex), 6th floor
Title: Phase 3 Study of the
Efficacy and Safety of Meloxicam IV in Subjects with Moderate to
Severe Pain following AbdominoplastyPoster #:
5166Date and Time: April 19, 2018 at 8:00-9:45 am
ETLocation: Uris (Shubert Complex), 6th floor
Title: Phase 3 Study of the
Efficacy and Safety of Meloxicam IV in Subjects with Moderate to
Severe Pain following Bunionectomy Poster #:
5167Date and Time: April 19, 2018 at 8:00-9:45 am
ETLocation: Uris (Shubert Complex), 6th floor
Title: A Phase 3,
Placebo-Controlled Study of Meloxicam IV Following Major
Surgery: Safety and Opioid Use in the Overall
PopulationPoster #: 5171Date and
Time: April 19, 2018 at 8:00-9:45 am
ETLocation: Uris (Shubert Complex), 6th floor
Title: A Phase 3,
Placebo-Controlled Study of Meloxicam IV Following Major Surgery:
Safety and Opioid Use Following Major Orthopedic
ProceduresPoster #: 5174Date and
Time: April 19, 2018 at 8:00-9:45 am ET
Location: Uris (Shubert Complex), 6th floor
Title: A Phase 3,
Placebo-Controlled Study of Meloxicam IV Following Major Surgery:
Safety and Opioid Use in Subjects of Advanced Age with Impaired
Renal Function Poster #: 5175Date and
Time: April 19, 2018 at 8:00-9:45 am
ETLocation: Uris (Shubert Complex), 6th floor
Title: Safety and Efficacy of
Meloxicam IV following Laparoscopic Abdominal SurgeryPoster
#: 5180Date and Time: April 19, 2018 at
8:00-9:45am Location: Uris (Shubert Complex), 6th
floor
Title: Meloxicam IV Dose
Selection: Results of a Population Pharmacokinetic and
Exposure-Response Analysis for the Management of Moderate to Severe
PainPoster #: 5181Date and Time:
April 19, 2018 at 5:50-6:00 pm ETLocation: Exhibit
Hall EX-01, Screen 7
Downloadable copies of the posters can be
accessed by visiting the “Investors” section of the Recro Pharma
website and by clicking “Presentations.”
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(973)
361-1546 david.rosen@argotpartners.com
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