FDA Approves Meloxicam Injection For Moderate-to-Severe Pain in Adults

Meloxicam injection (Xifyrm; Azurity Pharmaceuticals, Inc) received FDA approval for use in adults for the management of moderate to severe pain, either alone or in combination with nonsteroidal anti-inflammatory drug (NSAID) analgesics. The approval offers patients a new intravenous (IV) formulation of meloxicam.

Young woman suffering from chronic pain | Image Credit: © Goffkein - stock.adobe.com

The approval comes amid ongoing efforts across the US to reduce reliance on opioids for pain management. Multimodal pain control has become a widely endorsed approach in both perioperative and acute care settings. NSAIDs such as meloxicam play a key role in these regimens, as they reduce inflammation and provide analgesia without the addiction risk associated with opioids.¹

Meloxicam injection offers once-daily dosing in a 30-mg/mL vial and is administered via IV bolus injection over 15 seconds. The convenience of once-daily dosing and a rapid IV bolus administration may offer workflow efficiencies in hospital or surgical settings, where minimizing polypharmacy and streamlining medication administration are important goals. The approval also aligns with FDA and Centers for Medicare & Medicaid Services (CMS) incentives to encourage the development and use of nonopioid analgesics, particularly in light of the opioid crisis.¹

"[Meloxicam injection] demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management," Ron Scarboro, chief executive officer at Azurity Pharmaceuticals, said in a news release. "[Meloxicam injection] addresses an important clinical need, especially for patients requiring a nonopioid component to multimodal analgesia strategies."²

Meloxicam injection joins a growing market of IV NSAIDs, such as ketorolac and ibuprofen. However, meloxicam’s pharmacologic profile—specifically its preferential inhibition of cyclooxygenase-2—may offer certain clinical advantages, including a potentially lower risk of gastrointestinal adverse effects than nonselective NSAIDs.³

Although meloxicam injection delivers a nonopioid alternative for pain control, it is not recommended as a first-line agent when rapid onset of analgesia is needed due to its delayed onset. Additionally, like all NSAIDs, meloxicam injection should be used with caution in patients with cardiovascular, gastrointestinal, or renal risk factors.²

REFERENCES

1. Schwenk E, Mariano E, et al. Designing the ideal perioperative pain management plan starts with multimodal analgesia. Korean Journal of Anesthesiology. August 24, 2018. doi:10.4097/kja.d.18.00217

2. Azurity Pharmaceuticals announces the FDA approval of XIFYRM™ (meloxicam injection) for the management of moderate-to-severe pain in adults. PR Newswire. June 10, 2025. Accessed June 10, 2025. https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-announces-the-fda-approval-of-xifyrm-meloxicam-injection-for-the-management-of-moderate-to-severe-pain-in-adults-302477788.html

3. Furst D. Meloxicam: Selective COX-2 inhibition in clinical practice. Seminars in Arthritis and Rheumatism. December 21, 2004. doi:10.1016/S0049-0172(97)80049-2