Recro Pharma announced positive results from the Phase 3 study for intravenous (IV) meloxicam (N1539) for the treatment of acute postoperative pain in patients following bunionectomy surgery.
The study was a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of postoperative IV meloxicam vs. placebo in 201 patients undergoing bunionectomy surgery. The primary endpoint was the difference in Summed Pain Intensity Difference (SPID) over the first 48 hours (SPID48) compared to placebo.
Results showed that IV meloxicam achieved the study’s primary endpoint, demonstrating a statistically significant reduction in SPID48 (P=0.0034) vs. placebo. Additionally, patients treated with IV meloxicam also achieved 15 of the 19 secondary endpoints, including statistically significant differences in SPID6 (P=0.0153), SPID12 (P=0.0053), SPID24 (P=0.0084), SPID24-28 (P=0.0050), and time to first use of rescue medication (P=0.0076), compared to placebo-treated patients. IV meloxicam demonstrated a favorable and tolerable safety profile, with the most common adverse events of nausea, headache, pruritus, constipation, vomiting, dizziness, flushing and somnolence. No serious adverse events or bleeding were observed in the meloxicam arm.
Recro plans to submit detailed findings from this study for publication and presentation at a future scientific conference. The Company anticipates a New Drug Application submission to the FDA for IV meloxicam in mid-summer 2017, assuming positive results from an ongoing additional Phase 3 trial.
Meloxicam is a long-acting, preferential COX-2 inhibitor.
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