Meloxicam injection gets approval for management of moderate-severe pain

  • Food and Drug Administration

  • Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • Meloxicam injection (Baudax Bio, Inc.) for adults with moderate to severe pain has received approval from the FDA.

Why this matters

  • Meloxicam injection is the only available 24-hour intravenous (IV) cyclooxygenase-2 preferential NSAID.
  • EMA information on meloxicam-based drugs is available here.

Key points

  • For use with or without other non-NSAID analgesics.
  • Dosage: 30 mg once daily by IV bolus injection over the course of 15 seconds.
  • Meloxicam injection alone is not recommended for acute pain.
  • Contraindicated with a history of asthma, urticaria, or other allergic-type reactions after receiving aspirin or other NSAIDs.
  • Concomitant use with analgesic doses of aspirin is not recommended.
  • Approval based on 2 randomized, double-blind, placebo-controlled, phase 3 trials in patients with postoperative pain who received meloxicam injection or placebo once daily:
    • In 201 adults who underwent bunionectomy, meloxicam injection was associated with a significant decrease in the sum of the pain intensity differences (SPID) at 48 hours (P=.0034), longer time to first dose of rescue medication (P=.0076), and fewer patients using rescue medication (P<.001>
    • In 219 adults who underwent abdominoplasty, meloxicam injection was associated with a significant decrease in SPID (P=.0145) and fewer patients using rescue medication at 24-48 hours (P=.0014).
  • Most common adverse events include constipation, increased gamma-glutamyl transferase, and anemia.

Prescribing information