Malvern, Penn.-based Recro Pharma Inc. said the U.S. Food and Drug Administration rejected the new drug application for its non-opioid painkiller intravenous meloxicam.
In a complete response letter, or CRL, the U.S. FDA said that even though the outcome of the pivotal phase 3 trials demonstrated statistically significant outcomes on the primary endpoints, the agency 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. The regulator also raised concerns regarding the chemistry, manufacturing, and controls on extractable and leachable data provided in the application.
The company said it stands behind the evidence included in its application and seeks to hold further discussions with the FDA. "We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL," said Gerri Henwood, president and CEO of Recro Pharma.
