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FDA approval for Baudax Bio's non-opioid painkiller Anjeso

Published on 24/02/20 at 10:17am

Baudax Bio has revealed the FDA approval of its non-opioid painkiller Anjeso (meloxicam injection) as a therapy for the management of moderate to severe pain, either when administered as a monotherapy or when used in combination with analgesics which are not nonsteroidal anti-inflammatory drugs (NSAIDS).

The decision was based on efficacy data from two Phase 3 studies and marks the first availability in the US of a 24-hour, intravenous (IV) COX-2 preferential NSAID.

The drug is taken as a once-a-day intravenous (IV) bolus push, with its active ingredient offering “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 approval of Anjeso marks an important achievement for the medical community given the unmet need for non-opioid options in the pain treatment landscape,” remarked 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.”

Baudax Bio was launched in November last year after spinning out from Recro Pharma.

Gerri Henwood, President and Chief Executive Officer of Baudax Bio, also commented: “The approval of Anjeso marks a major advancement in the treatment landscape for managing moderate to severe pain,” “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.”

Matt Fellows

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