Recro Pharma (REPH) Announces CRL from FDA for IV meloxicam NDA

May 24, 2018 7:04 AM EDT

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Recro Pharma, Inc. (Nasdaq: REPH) 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.

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.

Conference Call and Webcast

Recro Pharma management will be hosting a conference call and webcast today beginning at 8:00 a.m. ET. To access the conference call, please dial (844) 243-4691 (local) or (225) 283-0379 (international) at least 10 minutes prior to the start time and refer to conference ID 9385399. A webcast will be available in the investor relations section of the Company's website, A live audio webcast of the call will be available under "Events" in the Investor section of the Company's website, An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 60 days.

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