Complete response letter for N 1539 (i.v.meloxicam) for acute post surgical pain.- Recro Pharma.
Recro Pharma, Inc. announced it has received a Complete Response Letter (CRL) from the FDA Office of Drug Evaluation II regarding the New Drug Application (NDA) for N 1539 ( IV meloxicam).
The CRL stated that although the outcome of the pivotal phase III trials demonstrated statistically significant outcomes on the primary endpoints, the FDA is unable to approve the application in its current form. The CRL states that data from ad hoc analyses and selective secondary endpoints suggest that the analgesic effect does not meet the expectations of the FDA. In addition, the CRL raised CMC related questions on extractable and leachable data provided in the NDA.
Comment: The agency’s decision is setback for the concern to find alternatives to addictive opioids, which have resulted in an average of 115 deaths per day from overdoses, according to the U.S. Centers for Disease Control and Prevention. It is also a major blow to Recro Pharma, whose IV meloxicam would have been the company’s first drug in the market.
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