Recro Pharma to Present IV Meloxicam Data at the 43rd Annual Regional Anesthesiology and Acute Pain Medicine Meeting

MALVERN, Pa., April 16, 2018 (GLOBE NEWSWIRE) -- 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:

  • Eugene Viscusi, MD

      Director, Acute Pain Management, Thomas Jefferson University
       

  • Jeff Gudin, MD

      Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center
       

  • Sabry Ayad, MD

      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 IV
Poster #: 5097
Date and Time: April 19, 2018 at 8:00-9:45 am ET
Location: 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 Abdominoplasty
Poster #: 5166
Date and Time: April 19, 2018 at 8:00-9:45 am ET
Location: 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 #: 5167
Date 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 the Overall Population
Poster #: 5171
Date 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 Following Major Orthopedic Procedures
Poster #: 5174
Date 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 #: 5175
Date and Time: April 19, 2018 at 8:00-9:45 am ET
Location: Uris (Shubert Complex), 6th floor

Title: Safety and Efficacy of Meloxicam IV following Laparoscopic Abdominal Surgery
Poster #: 5180
Date 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 Pain
Poster #: 5181
Date and Time: April 19, 2018 at 5:50-6:00 pm ET
Location: 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 Partners
Susan Kim/Natalie Wildenradt
(212) 600-1902
susan@argotpartners.com
natalie@argotpartners.com

Recro Pharma, Inc.
Michael Celano
(484) 395-2413
mcelano@recropharma.com

Media Contact:
Argot Partners
David Rosen
(973) 361-1546
david.rosen@argotpartners.com

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Source: Recro Pharma, Inc.