Baudax Bio Announces PDUFA Date for Intravenous Meloxicam

PDUFA Goal Date Set for February 20, 2020

MALVERN, Pa., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a specialty pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA goal date of February 20, 2020 for its decision on the New Drug Application (NDA) for intravenous (IV) meloxicam for the management of moderate to severe pain. The assignment of this PDUFA goal date follows the FDA’s acceptance of Baudax’s latest complete response package relating to its 2019 complete response letter (CRL) and appeal filing, seeking approval for IV meloxicam.

“We are pleased by the FDA’s acceptance of our latest response package, which we believe addresses their concerns and which includes proposed labeling for IV meloxicam for the management of moderate to severe pain, alone or in combination with other analgesics,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “We will be working closely with the FDA as they complete their review of the IV meloxicam NDA and work toward the PDUFA goal date.”

In October 2019, Baudax (through its former parent, Recro Pharma, Inc.) received a written decision from the FDA granting the appeal of the CRL the Company had previously received (in March of 2019) relating to its IV meloxicam NDA.

About Intravenous Meloxicam

Baudax holds exclusive global rights to Intravenous (IV) meloxicam, an NDA-pending non-opioid analgesic developed for the treatment of moderate to severe pain. If approved, IV meloxicam will be a novel IV non-opioid option for patients with moderate to severe pain. IV meloxicam successfully completed three Phase III clinical studies, including two Phase III efficacy studies and one Phase III safety study, four Phase II clinical studies, as well as other safety studies. The active ingredient meloxicam is a long-acting, preferential COX-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. 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).