FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Denies Recro Pharma’s Intravenous Meloxicam A Second Time

April 2, 2019

The FDA has once again put the brakes on Recro Pharma’s efforts to bring its pain killer meloxicam to market, the company has acknowledged.

In a complete response letter, regulators took issue with the non-opioid drug’s delayed onset, which they said failed to meet expectations for IV drugs. The agency also had concerns regarding the drug’s role as a monotherapy in acute pain and questioned its ability to meet patient and prescriber needs after analyzing clinical trial data.

Recro, a Malvern, Penn.-based specialty drugmaker said it strongly disagrees with the FDA’s decision and will continue pursuing the agency’s approval as it worked “to determine the best path forward.”

“We are extremely disappointed with the receipt of a second CRL from the FDA,” said Gerri Henwood, the company’s CEO. “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.”

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