This report summarizes the US Food and Drug Administration’s approval of Xifyrm™,a meloxicam intravenous formulation for adults requiring moderate to severe analgesia, either as monotherapy or adjunctive to non-NSAID agents. Approval was granted on the basis of pivotal postoperative pain studies (ClinicalTrials.gov Identifiers: NCT02675907; NCT02678286), which demonstrated meloxicam’s efficacy as an injectable NSAID.
Xifyrm is supplied in single dose vials containing 30 mg/mL meloxicam, with a recommended regimen of 30 mg once daily administered via 15 second intravenous bolus. In the referenced trials, analgesia onset exhibited a median latency of 2–3 hours; therefore, rapid onset relief may necessitate coadministration of a short-acting, non-NSAID, immediate release analgesic if analgesic response is deemed inadequate.
As with all NSAID therapies, Xifyrm carries a Boxed Warning for serious cardiovascular and gastrointestinal risks. The most frequently reported adverse reactions included constipation, elevations in gamma glutamyl transferase, and anemia. Renal function optimization via adequate patient hydration is advised to mitigate nephrotoxicity.
Therefore, Xifyrm introduces a non opioid, intravenous modality to multimodal analgesia protocols; however, its delayed analgesic onset and inherent NSAID risks underscore the need for careful patient selection, monitoring, and potential adjunctive analgesic strategies to ensure optimal pain control.
