Recro Pharma Receives Complete Response Letter from the FDA

Recro Pharma (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for the hospital and other acute care settings, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) Office of Drug Evaluation II regarding the New Drug Application (NDA) for IV meloxicam.

As quoted in the press release:

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.

“We are extremely disappointed for patients and providers who are looking for a non-opioid alternative for relief of pain.  We stand behind the body of evidence included in our NDA and are committed to further discussions with FDA in order to bring this important medicine to patients.  We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and look forward to working with the Agency to find solutions that can contribute to solving the current opioid public healthcare problem,” said Gerri Henwood, President and Chief Executive Officer of Recro.

Click here to read the full press release.