IV Meloxicam Receives Second CRL from FDA

The FDA’s response noted that the onset and duration of intravenous meloxicam would not meet prescriber expectations for an IV drug.

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for intravenous meloxicam for the management moderate to severe pain.

This is the second CRL that Recro Pharma has received for intravenous (IV) meloxicam. According to a statement from the company, the FDA’s response focused on the onset and duration of intravenous meloxicam. The FDA noted that a delayed onset does not meet prescriber expectations for intravenous drugs like meloxicam. There were also concerns about its use as a monotherapy in the treatment of acute 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, in a statement. “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.”

Despite receiving a second CRL, Henwood indicated that the company will continue to pursue an approval for IV meloxicam for this indication, will request a meeting with the FDA, and work with the FDA to find a path forward.

Henwood also highlighted that IV meloxicam is a non-opioid candidate for pain reduction in a time of a widespread opioid crisis in the United States.

“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,” she said.