Exhibit 99.1
FDA Grants Appeal to Recro Pharma for IV Meloxicam New Drug Application
Received Positive Response from FDA Regarding IV Meloxicam Formal Dispute Resolution Request
Company Remains on Track to Execute Spin Out of Acute Care Business Segment During the Fourth Quarter of 2019
MALVERN, Pa., October 31, 2019 – Recro Pharma, Inc. (NASDAQ:REPH), a specialty pharmaceutical company with a high-performing revenue generating contract development and manufacturing (CDMO) division, today announced that it has received a written decision from the U.S. Food and Drug Administration (FDA) granting its appeal of the Complete Response Letter relating to the New Drug Application (NDA) seeking approval for intravenous (IV) meloxicam.
The FDA’s letter states that the appeal was granted “specific to the request…that the NDA provides sufficient evidence of effectiveness and safety to support approval.” The letter also states that “before IV meloxicam can be approved and legally marketed, agreed-upon labeling (prescribing information) must be negotiated with the Division.”
The Company is now in the process of preparing a comprehensive response to the FDA that includes proposed labeling that aligns with the FDA guidance received in the written decision letter and provides the relevant evidence from the filed NDA to ensure safe and effective use of IV meloxicam by prescribers.
“This positive response is very good news for Recro and the patients and providers who will benefit from the availability of this product,” said Gerri Henwood, Recro Pharma’s President and Chief Executive Officer. “We are grateful for the expert advice we received from our advisors as well as for the time and attention of the FDA in this matter.”
The Company continues to expect that the spin out of the Recro Pharma Acute Care segment into an independently traded company will proceed as planned, and is expected to be concluded during the fourth quarter of 2019.
About IV Meloxicam
The active ingredient in Recro’s investigational drug is meloxicam, a long-acting, preferentialCOX-2 inhibitor that exhibits analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. Recro’s IV meloxicam was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).
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