FDA

IV NSAID OK’d for moderate to severe pain

June 13, 2025

Brand name: Xyfirm

Generic name: meloxicam injection

Manufacturer: Azurity Pharmaceuticals

Approval date: June 9, 2025

FDA approved Xifyrm (meloxicam injection) for use in adults for the management of moderate to severe pain, alone or in combination with non-NSAID analgesics.

According to the Prescribing Information, because of delayed onset of analgesia, Xifyrm alone is not recommended for use when rapid onset of analgesia is required.

Efficacy

Efficacy and safety of meloxicam injection in the treatment of moderate to severe pain was evaluated in two phase 3 randomized, double-blind, placebo-controlled, multiple-dose clinical trials in patients with postoperative pain. In study 1 (NCT02675907), 201 patients undergoing bunionectomy surgery were treated with meloxicam injection 30 mg or placebo administered once daily for two days starting on the day after surgery. In study 2 (NCT02678286), 219 patients undergoing elective abdominoplasty were treated with meloxicam injection 30 mg or placebo administered once daily for two days starting on the day of surgery. In both trials, oral oxycodone 5 mg was permitted as rescue medication for pain management.

Safety

The most common adverse reactions (≥2% and greater than placebo) in controlled clinical trials were constipation, increased GGT, and anemia.

Recommended dose

The recommended dosage of Xifyrm is 30 mg once daily, administered by IV bolus injection over 15 seconds. If analgesic response is inadequate, a short-acting, non-NSAID, immediate-release analgesic should be given.

Sources:

Zifyrm (meloxicam injection) [package insert] Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218395s000lbl.pdf Revised June 2025. Accessed June 12, 2025.

Azurity Pharmaceuticals announces the FDA approval of Xifyrm™ (meloxicam injection) for the management of moderate-to-severe pain in adults. [News release]. 2025. https://azurity.com/azurity-pharmaceuticals-announces-the-fda-approval-of-xifyrm-meloxicam-injection-for-the-management-of-moderate-to-severe-pain-in-adults/