Baudax Bio Announces FDA Approval of ANJESO for the Management of Moderate to Severe Pain

ANJESO Is The Only Approved 24-Hour, Intravenous COX-2 Preferential NSAID that Offers Once-Daily Dosing

U.S. Commercial Launch Planned to Commence in Late April or Early May 2020

Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

MALVERN, Pa., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ANJESO (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

“The approval of ANJESO marks a major advancement in the treatment landscape for managing moderate to severe pain,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “With our nation currently in the midst of a national opioid epidemic, we are thrilled to be able to offer a novel, non-opioid therapeutic option with the potential to meaningfully impact the acute pain treatment paradigm.  We expect to make ANJESO available to physicians and patients in late April or early May 2020.”

ANJESO is approved for the management of moderate to severe pain and will be administered as a once-a-day intravenous (IV) bolus push. ANJESO is the only available 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) and offers once-daily dosing.  The active ingredient meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis.

“The safety and efficacy of ANJESO have been well-established through several mid- and late-stage clinical studies,” said Stewart McCallum, M.D., Chief Medical Officer of Baudax Bio. “Moreover, data from our Phase III safety trial demonstrated that ANJESO is well tolerated and impacted opioid consumption compared to placebo, further highlighting its value to patients, providers and health systems.”

“The approval of ANJESO marks an important achievement for the medical community given the unmet need for non-opioid options in the pain treatment landscape,” said Dr. Keith Candiotti chair of the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami.  “While traditional opioid medications have proven effective at providing pain relief, the associated adverse side effects, including sedation and respiratory depression, have driven physicians to employ a multi-modal approach to treating post-operative pain. With 24-hour, durable pain relief and a safety profile comparable to placebo, ANJESO has the potential to serve as a meaningfully differentiated analgesic alternative.”