times (CTs) as untreated controls and numerically shorter CTs than ketorolac. In contrast, significant CT prolongations were observed in ketorolac samples compared with untreated control. These results suggest that IV meloxicam has the potential to provide a meaningful clinical benefit over ketorolac with respect to a decreased risk of platelet dysfunction.”
“NSAIDs are an integral part of the analgesic toolkit and are the physician’s first-line defense to prevent or treat pain,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Recro Pharma andco-author of the poster. “These compelling data continue to build upon the growing body of data supporting IV meloxicam’s safety and reinforce the positive safety findings elucidated by our comprehensive IV meloxicam development program. The IV meloxicam New Drug Application is currently under review by the U.S. Food and Drug Administration and we are currently awaiting our PDUFA goal date of March 24, 2019.”
A downloadable copy of the poster can be accessed by visiting the “Investors” section of theRecro Pharma website and clicking “Presentations.”
For more information on PGA72, visit: http://www.pga.nyc/.
About IV/IM Meloxicam
Meloxicam is a long-acting, preferentialCOX-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 preferentialCOX-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. Recro’s Complete Response to the CRL for IV meloxicam was accepted for filing by the FDA in early October 2018 and assigned a PDUFA date of March 24, 2019. As injectable meloxicam is in thenon-opioid class of drugs, if approved, the Company believes it has the potential to 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 and