The FDA approved the New Drug Application for a meloxicam injection (Anjeso, Baudax Bio), which is indicated for managing moderate to severe pain, alone or in combination with other non–nonsteroidal anti-inflammatory drug (NSAID) analgesics, according to a press release from the company.

The treatment is administered as a once-daily IV bolus push. It is the only available once-daily IV cyclooxygenase-2 preferential NSAID, according to the release.

“The approval of Anjeso marks an important achievement for the medical community given the unmet need for nonopioid options in the pain treatment landscape,” said Keith Candiotti, MD, an anesthesiologist and the chair of the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami.

The FDA approval was supported by two phase 3 efficacy studies and one double-blind, placebo-controlled, phase 3 safety study.

“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 multimodal approach to treating postoperative pain,” Dr. Candiotti said. “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.”

The therapy will be available in the United States by early May 2020, according to the release.

—PMN Staff

Dr. Candiotti reported serving as a consultant to Baudax Bio, and was an investigator on one clinical trial for Anjeso.