Phase III study of N 1539 (intravenous meloxicam) meets endpoint in acute postoperative pain- Recro Pharma

Recro Pharma has announced positive results from its second of two Phase III clinical trials evaluating N 1539 (intravenous 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). The IV meloxicam treatment arm demonstrated a statistically significant reduction in SPID24 compared to the placebo arm. The study also achieved statistical significance for 10 of the secondary endpoints, including statistically significant differences in SPID12, time to perceptible pain relief, subjects with at least 30% improvement at 24 hours, number of times patients required rescue in the first 24 hours after randomization, as well as number of times rescued from 24 to 48 hours, 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 (at least 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. There were no meaningful differences between treatment groups in vital signs, ECGs or clinical lab assessments.