IV Meloxicam Achieves Primary Endpoint of Statistically Significant Reduction in SPID24 in Patients with Acute Postoperative Pain Following Abdominoplasty SurgeryTen Secondary Endpoints Also MetCompany Estimates Filing US NDA in Summer 2017 MALVERN, Pa., Nov. 28, 2016 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on products for hospital and ambulatory care settings, currently developing non-opioid products for the treatment of serious acute pain, today announced positive results from its second of two Phase III clinical trials evaluating intravenous (IV) meloxicam for the treatment of acute postoperative pain. In this trial, IV meloxicam achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 24 hours (SPID24), compared to placebo, in patients following abdominoplasty surgery. With the positive data from this study, the Company believes this completes the efficacy program for the IV meloxicam New Drug Application (NDA). In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 219 patients were enrolled and randomly assigned to receive a postoperative regimen of IV meloxicam (30mg bolus injection) or placebo in a 1:1 ratio, once every 24 hours. The IV meloxicam treatment arm demonstrated a statistically significant reduction in SPID24 (p=0.0145) compared to the placebo arm. The study also achieved statistical significance for 10 of the secondary endpoints, including statistically significant differences in SPID12 (p=0.0434), time to perceptible pain relief (p=0.0050), subjects with =30% improvement at 24 hours (p=0.0178), number of times patients required rescue in the first 24 hours after randomization (p=0.0275), as well as number of times rescued from 24 to 48 hours (p=0.0009), and several other pain relief metrics, compared to placebo. The safety results demonstrated that IV meloxicam was well tolerated with no difference in serious adverse events (SAEs) related to bleeding for IV meloxicam treated patients versus placebo (1 each). There were two additional SAEs observed in the placebo group. The most common (=2% in the IV meloxicam group) adverse events (AEs) were nausea, headache, vomiting, and dizziness. The incidence of these events was lower than those observed in the placebo group. The majority of AEs were mild in nature and one patient in the placebo group discontinued treatment due to an adverse event of post-procedural bleeding.