Recro Pharma, Inc. , a revenue generating specialty pharmaceutical company focused on therapeutics for hospital and other acute care settings announced the presentation of clinical data from its Phase III study evaluating intravenous (IV) meloxicam 30mg for the treatment of acute postoperative pain in patients following bunionectomy surgery, at the American Pain Society 36th Annual Scientific Meeting, taking place May 17-20, 2017, in Pittsburgh, PA.
The poster presentation highlights the clinical performance of IV meloxicam 30mg, including achievement of the study’s primary endpoint, a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 48 hours (SPID48) compared to placebo, along with detailed secondary endpoints and safety results.
“The detailed Phase III results presented at the American Pain Society annual meeting highlight the clinical performance of IV meloxicam 30mg and the key features it can offer clinicians who are seeking non-opioid pain relief alternatives for their patients recovering from surgery,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer for Recro Pharma and co-author of the poster. “The data from this late-stage trial demonstrate that IV meloxicam 30mg provides rapid and sustained pain relief following bunionectomy surgery, a favorable safety and tolerability profile, and statistically significant differences in rescue use and numerous other pain relief metrics, including length of time to opioid rescue and number of patients utilizing opioid rescue analgesia, among others.”
Gerri Henwood, President and Chief Executive Officer of Recro, commented, “These exciting data demonstrate the key clinical attributes of IV meloxicam 30mg and support its potential as a new, non-opioid pain treatment option. If approved, IV meloxicam will be the only intravenously administered, once-daily, non opioid pain product and we believe it will play a meaningful role in the physician’s analgesic toolkit. The data from this pivotal clinical trial in bunionectomy, together with the positive results from our Phase III trial in patients following abdominoplasty surgery and the positive Phase III safety trial results reported last week, will form the basis of a New Drug Application (NDA) for IV meloxicam 30mg for the treatment of moderate-to-severe pain, which we plan to file with the U.S. Food and Drug Administration during early third quarter 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 a NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds.
About Recro Pharma, Inc.
Recro 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 has successfully completed four Phase II clinical trials in the management of moderate to severe post-operative pain and two pivotal Phase III clinical efficacy trials in patients following bunionectomy and abdominoplasty surgeries, as well as a large double blind Phase III safety trial and 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 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.
Investor Relations Contact:
Susan Kim/Natalie Wildenradt
Recro Pharma, Inc.