Recro Pharma, Inc. announced positive results from its Phase II clinical trial evaluating intravenous (IV) meloxicam for the treatment of acute pain following bunionectomy surgery. The primary objective of the trial was to evaluate the safety of IV meloxicam when administered as a bolus injection (over 15-30 seconds) and the primary efficacy endpoint was evaluation of Summed Pain Intensity Difference over 48 hours (SPID48) scores and secondary endpoints evaluated additional efficacy parameters and pharmacokinetics. Safety: The safety results demonstrated that IV meloxicam was well tolerated with no serious adverse events, bleeding events or injection site reactions.

The most common adverse events (AEs) were nausea, headache, dizziness, pruritus and vomiting, and were comparable to the placebo group. There were no discontinuations due to AEs. The majority of treatment emergent AEs (TEAEs) were mild in nature and determined by investigators to be not related or possibly related to study drug.

There were no vital signs changes that necessitated treatment. There were no observed changes in the evaluation of ECGs. No clinically meaningful lab changes were observed in the meloxicam treatment groups.

Efficacy: The primary efficacy endpoint of the trial was SPID48 (0-48). Secondary efficacy endpoints included use of opioid rescue medication, SPIDs over various time intervals, and patient global assessment (PGA) of pain control. Both the 30mg and 60mg IV meloxicam treatment arms demonstrated statistically significant reductions in pain intensity, as measured by SPID48 (p=0.007 and p=0.0027, respectively) compared to placebo.

Although there were observed differences in opioid consumption among the meloxicam dose groups and the placebo group, in general these differences did not meet statistical significance.