General Information

Anjeso (meloxicam) injection is a long-acting non-steroidal anti-inflammatory drug (NSAID) with preferential COX-2 inhibition that possesses anti-inflammatory, analgesic, and antipyretic activities.

Anjeso is specifically indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

Anjeso is supplied as a solution to be administered as a once-a-day intravenous (IV) bolus push.

Clinical Trials

FDA Approval

The FDA approval of Anjeso was based on the following studies:

Phase 3 Efficacy Study Evaluating Anjeso Following Bunionectomy Surgery:

In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 201 patients were enrolled and randomly assigned to receive a postoperative regimen of Anjeso (30mg) or placebo in a 1:1 ratio, once every 24 hours for up to 3 doses following bunionectomy surgery, a representative hard tissue surgery. The Anjeso treatment arm demonstrated a statistically significant reduction in summed pain intensity difference from baseline during the 48 hours (SPID48) compared to the placebo arm. The study also achieved 15 of the 19 secondary endpoints, including statistically significant differences in SPID6, SPID12, SPID24, SPID24-48, time to first use of rescue medication, and several other rescue use and pain relief metrics during the first 48 hours, compared to placebo.

Phase 3 Efficacy Study Evaluating Anjeso Following Abdominoplasty Surgery

In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 219 patients were enrolled and randomly assigned to receive a postoperative regimen of Anjeso (30mg bolus injection) or placebo in a 1:1 ratio, once every 24 hours. The Anjeso treatment arm demonstrated a statistically significant reduction in SPID24 compared to the placebo arm. The study also achieved statistical significance for 10 of the secondary endpoints, including statistically significant differences in SPID12, time to perceptible pain relief, subjects with ≥30% improvement at 24 hours, number of times patients required rescue in the first 24 hours after randomization, as well as number of times rescued from 24 to 48 hours, and several other pain relief metrics, compared to placebo.

Phase 3 Safety Study Evaluating Anjeso Following Major Surgery

This multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, included patients who had undergone major elective surgical procedures which were expected to result in hospitalization for at least 24-48 hours. Major surgical procedures included total hip and knee replacements, spinal, GI, hernia repair, and gynecologic surgeries, as well as a range of other surgeries. Patient demographics were balanced across treatment groups and included 40% male patients and about 23% of patients who were over age 65. Unlike the pivotal efficacy trials, minimum pain scores were not required for treatment. Sites were permitted to use opioids and other pain management modes according to their “standard of care” and meloxicam or placebo was added to this regimen. Patients were randomized in a 3:1 ratio to receive either Anjeso or IV placebo daily for up to 7 doses. A total of 721 patients received at least one dose of study medication. In patients age 65 and over, the percentage of patients reporting at least one AE was approximately 7% less in the Anjeso treatment arm compared to the placebo arm. The total occurrence of patients with at least one serious adverse event (SAE) was observed to be lower in the Anjeso group, 2.6%, (14/538 meloxicam patients) than in the placebo group, 5.5%, (10/183 placebo patients). In this safety study only two SAE events were listed as possibly related to study treatment. Both of these SAEs occurred in one placebo treated patient. No deaths were reported in either treatment group. Approximately 3% of patients in each study group discontinued.

Mechanism of Action

Anjeso (meloxicam) is a long-acting NSAID with preferential COX-2 inhibition that possesses anti-inflammatory, analgesic, and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. The injectable form of the drug, which utilizes Alkermes NanoCrystal technology, provides a faster onset of action compared to oral meloxicam, thus providing a rapid and sustained treatment for acute pain via the intravenous (IV) or intramuscular (IM) administration routes.