Recro Pharma Announces Publication of Supportive Phase II IV Meloxicam Bunionectomy Data in the Journal of Pain Research
MALVERN, Pa., Feb. 20, 2018 (GLOBE NEWSWIRE) -- 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.
Recro Pharma, Inc.
Released February 20, 2018