The U.S. Food and Drug Administration has approved XIFYRM (meloxicam injection), marking the introduction of a new intravenous formulation of the NSAID meloxicam for managing moderate-to-severe pain in adults. Developed by Azurity Pharmaceuticals, the once-daily injection offers healthcare providers a non-opioid alternative for pain management strategies.
Clinical Indication and Administration
XIFYRM is indicated for use in adults for the management of moderate-to-severe pain, either alone or in combination with non-NSAID analgesics. The drug is supplied in a 30mg/mL vial and administered via IV bolus injection over 15 seconds, providing convenience through once-daily dosing.
However, the FDA approval comes with an important limitation: XIFYRM alone is not recommended for use when rapid onset of analgesia is required due to its delayed onset of analgesia profile.
Addressing the Opioid Crisis
The approval comes amid ongoing efforts across the United States to reduce reliance on opioids for pain management. Multimodal pain control has become a widely endorsed approach in both perioperative and acute care settings, with NSAIDs like meloxicam playing a key role in these regimens by reducing inflammation and providing analgesia without the addiction risk associated with opioids.
"XIFYRM demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management," said Ron Scarboro, CEO at Azurity Pharmaceuticals. "XIFYRM addresses an important clinical need, especially for patients requiring a non-opioid component to multimodal analgesia strategies."
Clinical Advantages and Market Position
The convenience of once-daily dosing and 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 incentives to encourage the development and use of non-opioid analgesics.
XIFYRM 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 side effects compared with non-selective NSAIDs.
Safety Considerations
Like all NSAIDs, meloxicam injection should be used with caution in patients with cardiovascular, gastrointestinal, or renal risk factors. The full prescribing information, including boxed warning and safety profile, is available at www.xifyrm.com.
Availability
XIFYRM will be available in the coming weeks, adding to Azurity Pharmaceuticals' diversified portfolio of 30+ marketed brands spanning ten dosage forms and ten key therapeutic areas across over 50 countries.
