Recro Pharma Inc REPH recently announced positive Phase 3 safety data for its palliative drug, IV Meloxicam, and CEO Gerri Henwood is eager to take the non-opioid, preferential COX-2 inhibitor to the next level.
The company looks to file a New Drug Application with the Food and Drug Administration early in the third quarter, although it could see minor delays as it waits on a final piece of laboratory data. Results are expected in early June to supplement trial findings and aid in post-manufacturing, pre-release testing.
“If that were to be a week later or something, we might be able to absorb it,” Henwood said. “If it were much later than that, it could impact the timing. We believe that, otherwise, we’re in pretty good shape.”
Justifying Results
Two Phase 3 Meloxicam trials for patients who underwent an abdominoplasty or bunionectomy met their primary endpoints for summed pain intensity difference and revealed no serious adverse effects, although some patients in the experimental group saw higher concentrations of the liver enzyme, GGT.
“The percentage difference between the placebo and the active group is not significant, but it is numerically observable, and we don’t have any specific explanation for it, nor do we have any specific concerns,” Henwood said. “So in this kind of an operative population, sometimes you see transient increases in this particular liver enzyme, and we saw that everybody returned to normal without any other treatment required in a pretty short period of time, so it is something we will continue to monitor in future studies, but it isn’t something that we think is an unusual occurrence or an area for clinical concern.”
Patients in the Meloxicam group also saw slightly higher rates of anemia than those in the placebo group, but Henwood considered the circumstance more coincidental than causal. More Meloxicam patients had lower hemoglobin and hematocrit counts to begin with, and those initiating the trial with normal levels and ending with reduced counts were fairly comparable across the placebo and experimental groups.
“There is not a significant difference between those, so our thinking right now is these may have been patients who were sort of borderline low before they started their surgery and the combination of surgery and treatment put them just over the border into anemia,” Henwood said. “But we haven’t seen this as a significant clinical problem.”
Recro Chief Medical Officer Stewart McCallum will present more details on the efficacy and safety of the bunionectomy study Thursday morning at the American Pain Society 36th Annual Scientific Meeting.
Nick Donato contributed reporting.
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