FDA issues Complete Response Letter to Recro Pharma relating to IV meloxicam

Recro Pharma, Inc. announced it has received a second Complete Response Letter (CRL) from the FDA Office of Drug Evaluation II regarding their New Drug Application (NDA) seeking approval for intravenous (IV) meloxicam for the management of moderate to severe pain.

“We are extremely disappointed with the receipt of a second CRL from the FDA,” said Gerri Henwood, President and Chief Executive Officer of Recro Pharma. “We remain steadfast in our belief that IV meloxicam holds significant potential as a treatment option for moderate to severe pain in multiple clinical settings and remain committed to pursuing a path to regulatory approval. We are dedicated to bringing this and other non-opioid pain products to the market to help address the crippling opioid epidemic our country currently faces, as we believe they are an important tool for patients and physicians to safely and effectively manage pain in multiple clinical settings. We intend to work closely with the FDA to determine the best path forward to obtain approval for IV meloxicam.”

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 intravenous (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.