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 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,” said Dr. Candiotti, who is also a member of the editorial advisory board for Anesthesiology News. “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.”