Recro Pharma announces publication of new IV meloxicam data
Recro Pharma announced the publication of new intravenous, or IV, meloxicam data. The articl was published online in Regional Anesthesia & Pain Medicine. A new drug application, or NDA, for IV meloxicam is currently under review by the FDA and the company is currently awaiting its assigned PDUFA goal date of March 24. The published data describe the pooled safety across a total of seven clinical studies, where IV meloxicam was evaluated in patients following several types of surgeries, including dental impaction surgery, open abdominal hysterectomy, abdominal laparoscopic surgery, bunionectomy, and abdominoplasty, among others. In this pooled analysis, IV meloxicam was generally well-tolerated, with the incidence of TEAEs occurring in a lower percentage of IV meloxicam-treated patients than in placebo-treated patients. The most commonly reported TEAEs across all treatment groups were nausea, headache, vomiting and dizziness. Notably, TEAE incidence was generally similar between the overall study populations and older patients with impaired renal function. There were no drug-related deaths for patients treated with IV meloxicam. Serious adverse events occurred at a lower frequency in the 30mg IV meloxicam treated group compared to the placebo group. In the Phase II/III postsurgical study program where opioid rescue medication consumption was monitored, IV meloxicam was often associated with prolonged time to first rescue medication use and reduced rescue medication requirements. In the Phase III, randomized, double-blind, placebo-controlled trial evaluating IV meloxicam following major surgery, IV meloxicam was associated with reduced opioid consumption. Mean opioid consumption in the overall population was significantly less in the IV meloxicam group compared with the placebo group. Decreased opioid use among patients treated with IV meloxicam compared with placebo-treated subjects was observed across all subgroups. In the IV meloxicam treatment group, decreased opioid use corresponded to fewer TEAEs commonly associated with opioid administration during the initial postoperative period. Additionally, in both the Phase II dental impaction and hysterectomy studies, the percentage of subjects using opioid medication after surgery was lower in the IV meloxicam group compared with the placebo group. Although a statistical evaluation was not conducted across the pooled studies, a trend indicating a decrease in adverse events commonly associated with opioid administration such as nausea, vomiting, constipation and pruritus was observed.