Recro Pharma CRL from FDA says meloxicam onset fails to meet expectations
Recro Pharma announced it has received a second complete response letter, or CRL, from the FDA Office of Drug Evaluation II regarding their new drug application, or NDA, seeking approval for intravenous, or IV, meloxicam for the management of moderate to severe pain. The FDA's comments in the CRL focused on onset and duration of IV meloxicam, noting that the delayed onset fails to meet the prescriber expectations for IV drugs. The CRL also cited regulatory concerns about the role of IV meloxicam as a monotherapy in acute pain, as well as how it would meet patient and prescriber needs in that setting, given the FDA's interpretation of the clinical trials data. The company strongly disagrees with FDA's interpretation and its views on the clinical utility of IV meloxicam in the acute pain setting. The FDA did not identify any CMC issues in this CRL. Recro intends to continue to pursue regulatory approval for IV meloxicam and will request a meeting with the FDA and work closely with them to resolve these issues.