Key Takeaways
- FDA Expands Non-Opioid Options: Xifyrm joins a growing list of FDA-approved non-opioid treatments for moderate-to-severe pain, supporting safer multimodal pain strategies.
- Rising Need for Alternatives: With roughly 85,000 Americans developing opioid use disorder each year, demand is increasing for effective, non-addictive pain management therapies.
- New Class of Pain Inhibitors Emerges: Vertex’s Journavx and Azurity’s Xifyrm highlight an industry shift toward innovative mechanisms, such as NaV1.8 channel inhibition and intravenous non-steroidal anti-inflammatory drugs, to reduce reliance on opioids.
The FDA has approved Azurity Pharmaceuticals’ Xifyrm (meloxicam injection) for the management of moderate-to-severe pain in adults. According to the company, the intravenous non-steroidal anti-inflammatory drug (NSAID) may be used alone or in combination with non-NSAID analgesics as part of a multimodal pain management strategy. Xifyrm is administered as a once-daily 30 mg/mL IV bolus injection over 15 seconds; however, due to its delayed onset of action, Xifyrm is not recommended as a standalone option when rapid pain relief is required.1
How Does Xifyrm Enhance Non-Opioid Pain Management Options?
"Xifyrm demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management," said Ron Scarboro, CEO, Azurity Pharmaceuticals, in a press release. "Xifyrm addresses an important clinical need, especially for patients requiring a non-opioid component to multimodal analgesia strategies."
What are the Key Safety Considerations for Xifyrm?
The product label carries a Boxed Warning for an increased risk of serious cardiovascular events, such as myocardial infarction and stroke, as well as serious gastrointestinal complications, including bleeding, ulceration, and perforation of the stomach or intestines. Additional warnings and precautions include risks of liver toxicity; diminished response to certain antihypertensive drugs; and worsening heart failure in patients with preexisting severe cardiac conditions.
Azurity also cautions that Xifyrm may impair renal function in individuals with kidney or liver impairment, heart failure, dehydration, or low blood volume. Other serious risks include anaphylaxis, asthma exacerbation in patients with aspirin sensitivity, severe skin reactions, blood-related toxicities, and fetal harm.2
How Does Xifyrm Fit into a Broader Shift Toward Non-Opioid Therapies?
Xifyrm isn’t the only non-opioid pain management drug to receive FDA approval this year. In January, the agency approved Vertex Pharmaceuticals’ Journavx (suzetrigine), a first-in-class, non-opioid pain signal inhibitor for adults with moderate-to-severe acute pain. Journavx works by selectively targeting NaV1.8 channels, delivering effective pain relief without evidence of addictive potential.
Roughly 80 million people in the United States are treated with medication for pain each year, with about half receiving an opioid prescription. However, a significant portion of these patients may go on to develop opioid use disorder within a year—accounting for approximately 85,000 new cases annually.3
Azurity expects to make Xifyrm available in the coming weeks.1
References
1. 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 11, 2025. https://prnmedia.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
2. Xifyrm FDA Approval History. Drugs.com. Accessed June 11, 2025. https://www.drugs.com/history/xifyrm.html
3. FDA Approves Vertex Pharmaceuticals’ First-in-Class Non-Opioid Journavx for Moderate-to-Severe Acute Pain. PharmExec. January 31, 2025. Accessed June 11, 2025. https://www.pharmexec.com/view/fda-approves-vertex-pharmaceuticals-first-class-non-opioid-journavx-moderate-severe-acute-pain
