The Food and Drug Administration (FDA) has sent a second Complete Response Letter (CRL) to Recro Pharma concerning their New Drug Application (NDA) for intravenous meloxicam.

The Agency first sissued a CRL regarding IV meloxicam in May, 2018. This first rejection stated that the analgesic effects demonstrated in ad hoc analyses, and selective secondary endpoints, did not meet the Agency’s expectations.

The Company’s response was then accepted in October 2018 with a Prescription Drug User Fee Act (PDUFA) date for March 2019.

In the second CRL, the FDA indicated that the delayed onset fails to meet the prescriber expectations for IV drugs. Regulatory concerns were also raised regarding the role of IV meloxicam as a monotherapy in acute pain. The Company stated that they strongly disagree with the FDA’s conclusions.

Meloxicam is a long-acting nonsteroidal anti-inflammatory drug (NSAID) with preferential COX-2 inhibition. IV meloxicam was developed using the NanoCrystal platform that allows enhanced bioavailability of poorly water-soluble drugs.

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“We are extremely disappointed with the receipt of a second CRL from the FDA,” said Gerri Henwood, President and CEO of Recro, “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.”

As part of their next steps, Recro says they will meet with the FDA “to resolve these issues.”

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