Recro Pharma Provides Regulatory Update for IV Meloxicam

Company Anticipates NDA Resubmission by the End of September 2018

Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for the hospital and other acute care settings, today provided a regulatory update following receipt of the official meeting minutes from a July 2018 Type A meeting with the U.S. Food and Drug Administration (FDA)relating to a path forward for intravenous (IV) meloxicam, the Company’s lead product candidate for the management of moderate to severe pain.

Recro had requested this Type A meeting with the FDA to address a Complete Response Letter (CRL) it received from the FDA regarding the New Drug Application (NDA) for IV meloxicam. During the meeting, Recro discussed data from ad hoc analyses and selective secondary endpoints of Recro’s clinical trials which the FDA had highlighted in the CRL, as well as CMC related questions on extractable and leachable data provided in the NDA.  Based upon the discussion with the FDA as reflected in the official meeting minutes, Recro anticipates resubmitting the IV meloxicam NDA by the end of September. The NDA resubmission will incorporate revised language relating to the product label and, additional information relating to extractable and leachable items.

“We are pleased with the constructive nature of our interactions with the FDA regarding IV meloxicam, and we expect to resubmit the NDA for IV meloxicam by the end of September,” said Gerri Henwood, President and Chief Executive Officer of Recro. “We remain fully committed to IV meloxicam and to bringing this new non-opioid treatment option for the management of moderate to severe pain to the physicians and patients who need it.”

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