Recro Pharma, Inc. announced that the first patient was dosed in the pivotal Phase III clinical trial evaluating intravenous (IV) meloxicam (N1539) for acute postoperative pain in patients following mini abdominoplasty surgery. In this multicenter, randomized, double-blind, placebo-controlled clinical trial, IV meloxicam's efficacy and safety will be evaluated in the management of postoperative pain following abdominoplasty surgery, a representative soft tissue surgery. Approximately 200 patients will be assigned randomly to a postoperative regimen of IV meloxicam (30mg) or placebo in a 1:1 ratio, once every 24 hours for up to 3 doses following surgery.

The primary efficacy endpoint of this Phase III study is the summed pain intensity difference over the first 24 hours (SPID24) compared to placebo. Recro expects to report top-line results from this Phase III study by year end 2016. Given the consistent encouraging clinical data from multiple Phase II trials in highly relevant pain models including bunionectomy, hysterectomy, dental and laparoscopic abdominal surgeries showing clear analgesic effect, the company looks forward to completing this pivotal Phase III trial in patients following soft tissue surgery.