FDA Rejects IV Pain Drug from Recro Pharma

FDA has issued Recro Pharma a complete response letter for intravenous (IV) meloxicam for managing moderate to severe pain. The letter focused on onset and duration of IV meloxicam, noting that the delayed onset fails to meet the prescriber expectations for IV drugs, according to the company. It 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 says.

Recro Pharma says it “strongly disagrees” with FDA’s interpretation and its views on the clinical utility of IV meloxicam in the acute pain setting. The agency did not identify any chemistry, manufacturing and control issues in the letter, it says, adding that a meeting will be requested to determine how to resolve the issues.