IV meloxicam effectively reduces opioid use following major surgery

Sergio D. Bergese

A novel IV formulation of meloxicam, a therapy in development to manage moderate to severe pain, demonstrated safety and tolerability in patients for up to 7 days after major surgery and significantly lowered their total opioid use compared with placebo, according to phase 3 study data presented at PAINWeek.

“There is a significant need for nonopioid pain management options with the potency of opioids,” Sergio D. Bergese, MD, director of neurosurgical anesthesia at the Ohio State University Wexner Medical Center, Columbus, told Healio Internal Medicine. “We may soon have an effective and safe postoperative pain treatment option that could help us reduce the use of opioids and hopefully avoid the issues commonly associated with them.”

In two recently completed placebo-controlled phase 3 studies, IV meloxicam, a new IV formulation of NanoCrystal Collodial Dispersion meloxicam, has been shown to provide rapid and sustained 24-hour pain relief and reductions in opioid use in patients with moderate to severe pain after hard and soft tissue surgeries.

In the current randomized, double-blind study, Bergese and colleagues compared the safety of administered IV meloxicam 30 mg with placebo for up to seven doses in patients aged 18 to 80 years scheduled to undergo major surgery with a hospital stay exceeding 24 hours. Patients could continue receiving opioid analgesia to treat uncontrolled pain symptoms. To determine safety of the therapy, researchers included laboratory tests, vital signs, ECGs, surgical wound examination and total opioid use, and monitored adverse events.

In total, 538 patients received IV meloxicam 30 mg and 183 received placebo.

The results showed that IV meloxicam 30 mg was well tolerated with no deaths and had a low incidence of serious adverse events compared with placebo (meloxicam, 2.6% vs. placebo, 5.5%) and withdrawals due to an adverse event (meloxicam, 0.4% vs. placebo, 0%). Mean opioid consumption was significantly lower with IV meloxicam compared with placebo (P < .05).

Researchers reported the following reductions in opioid consumption: 22% at 24 hours; 22.6% at 48 hours; and 23.7% at 72 hours. Patients who received IV meloxicam experienced a lower incidence of nausea and vomiting, which the researchers believe may have been related to the reduction in opioid use compared with placebo.

“The data from this phase 3 study support the safety and tolerability of IV meloxicam while also showing a statistically significant reduction on total opioid use compared to placebo,” Bergese said. “Coupled with data from the other phase 2 and phase 3 studies, there is a large body of evidence showing IV meloxicam appears to work faster and provide a longer duration of postoperative pain relief, and is generally well tolerated.” – by Savannah Demko

Reference:

Bergese SD, et al. Safety and opioid use in a phase 3, placebo-controlled study of intravenous meloxicam following major surgery. Presented at: PAINWeek; Sept. 5-9, 2017; Las Vegas.

Disclosure: Bergese reports no relevant financial disclosures.