Recro receives second CRL for IV meloxicam in pain

25 March 2019

A company that is seeking non-opioid solutions for acute pain is a step further from finding one after receiving a second complete response letter (CRL) relating to one of its candidates.

Recro Pharma (Nasdaq: REPH) received the letter from the US Food and Drug Administration regarding the New Drug Application (NDA) seeking approval for intravenous (IV) meloxicam for the management of moderate to severe pain.

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 IV drugs.

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