New data demonstrates IV meloxicam's effect on platelet function.- Recro Pharma

Recro Pharma, Inc. announced a poster presentation highlighting intravenous (IV) meloxicam's effect on platelet function at the 72nd PostGraduate Assembly in Anesthesiology (PGA72), sponsored by the New York State Society of Anesthesiologists (NYSSA), taking place December 7-11, 2018, in New York City. The poster, titled "An Ex-vivo Assessment of the Effects of Meloxicam IV on Platelet Function," which was presented by lead author Jonathan S. Jahr, M.D., David Geffen School of Medicine at UCLA, describes results from an ex vivo study assessing the effects of various concentrations of IV meloxicam (5mcg/mL, 10mcg/mL, 15mcg/mL and 20mcg/mL) on platelet function compared to ketorolac (2.5mcg/mL and 5mcg/mL) and an untreated control.

The 5mcg/mL concentration of IV meloxicam in this study corresponds to the maximum plasma levels following a 30mg dose in the clinical setting. Similarly, the 5mcg/mL concentration of ketorolac in this study corresponds to a 30mg and the 2.5mcg/mL dose corresponds to the 15mg dose in the clinical setting. In this study, blood samples provided by healthy volunteers (n=8) were analyzed to determine closure time (CT) following the addition of IV meloxicam and ketorolac at the previously mentioned concentrations to the blood plasma samples. The researchers conducted the analyses using a platelet function analyzer (PFA-100), a standard of care for platelet function testing, and two different reagents, collagen with epinephrine (CEPI) and collagen with adenosine diphosphate (CADP). In the CEPI reagent analysis, a significant treatment effect was observed for changes in CT (p=0.0441). No significant difference was observed in CT for the IV meloxicam treated samples versus the untreated control at any of the evaluated concentrations (p?0.5400). When compared to untreated control, the ketorolac treated sample CT values were significantly prolonged in both the 2.5mcg/mL and the 5mcg/mL concentrations (p?0.0257).

All IV meloxicam concentration levels had a significantly shorter CT compared to the 2.5mcg/mL ketorolac concentration (p<0.005). all iv meloxicam concentration levels had numerically shorter cts compared to the 5mcg ml ketorolac concentration, though only the 10mcg ml iv meloxicam concentration reached statistical significance. in the cadp reagent analysis, neither iv meloxicam nor ketorolac demonstrated a significant change in ct versus untreated control (p?0.0907).></0.005).>

"A concern around the use of non-steroidal anti-inflammatory drugs (NSAIDs) in the peri- or post-operative setting is the potential for platelet dysfunction and risk of bleeding related events," commented Dr. Jahr. "Our thesis here was that IV meloxicam's higher affinity for COX-2 inhibition, versus COX-1, would translate into a lower risk for platelet dysfunction. The data presented this year at PGA72 show that IV meloxicam achieved roughly the same closure times (CTs) as untreated controls and numerically shorter CTs than ketorolac. In contrast, significant CT prolongations were observed in ketorolac samples compared with untreated control. These results suggest that IV meloxicam has the potential to provide a meaningful clinical benefit over ketorolac with respect to a decreased risk of platelet dysfunction."

"NSAIDs are an integral part of the analgesic toolkit and are the physician's first-line defense to prevent or treat pain," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Recro Pharma and co-author of the poster. "These compelling data continue to build upon the growing body of data supporting IV meloxicam's safety and reinforce the positive safety findings elucidated by our comprehensive IV meloxicam development program. The IV meloxicam New Drug Application is currently under review by the U.S. Food and Drug Administration and we are currently awaiting our PDUFA goal date of March 24, 2019."