Phase III results for N 1539 in pain published in Clinical Journal of Pain.- Recro Pharma.

Recro Pharma announced the publication of Phase III clinical data for N 1539 (intravenous meloxicam) for the treatment of pain following bunionectomy surgery. The article, titled �Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-Severe Pain Following Bunionectomy,� was published online in the Clinical Journal of Pain.

The Phase III, multi-center, randomized, double-blind, placebo-controlled trial (n=201) was designed to evaluate the efficacy and safety of IV meloxicam 30mg for the management of moderate to severe pain following bunionectomy surgery. The primary efficacy endpoint was Summed Pain Intensity Difference (SPID) over 48 hours (SPID48). IV meloxicam 30mg achieved a statistically significant difference reduction in SPID48 (p=0.0034), as well as statistically significant reductions in SPID values at other times and intervals (SPID6, SPID12, SPID24, SPID24-48), among other key secondary endpoints. Additionally, an opioid-sparing effect was observed for IV meloxicam 30mg, indicated by a longer time to first use of rescue (p=0.0076), a lower number of subjects using rescue (p<0.001) and the lower mean number of per-subject rescue doses (p><0.05).>

IV meloxicam 30mg was well tolerated, with no associated serious adverse events (SAEs) or withdrawals due to adverse events (AEs). The majority of treatment-emergent adverse events in the IV meloxicam 30mg group were reported as mild or moderate in intensity, with incidence and intensity comparable to placebo.

See: "Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled Trial" Pollak, Richard et al. The Clinical Journal of Pain: March 16, 2018 - Volume Publish Ahead of Print - Issue - p doi: 10.1097/AJP.0000000000000609