24 May 2018 - Recro Pharma today announced it has received a complete response letter from the U.S. FDA Office of Drug Evaluation II regarding the new drug application for IV meloxicam.

The letter 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 letter 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 letter raised CMC related questions on extractable and leachable data provided in the application. 

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