Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain

Prolonged-release (PR; as ascribed in the EU) or extended-release (as ascribed in the USA) bupivacaine/meloxicam (HTX-011; hereafter referred to as bupivacaine/meloxicam PR; Zynrelef(R)) is a synergistic fixed-dose combination (FDC) of the local anaesthetic bupivacaine and the NSAID meloxicam. It is approved in the EU and the USA to treat postoperative pain. After needle-free application at the surgical site, the novel polymer technology allows simultaneous diffusion of bupivacaine and meloxicam over 72 h. In clinical trials, bupivacaine/meloxicam PR significantly reduced postoperative pain and opioid consumption relative to bupivacaine hydrochloride (HCl) and placebo in patients undergoing bunionectomy, herniorrhaphy or total knee arthroplasty (TKA). When used as the foundation of a scheduled non-opioid multimodal analgesia (MMA) regimen, bupivacaine/meloxicam PR further improved pain control and reduced the need for opioids following surgery. Bupivacaine/meloxicam PR was generally well tolerated, with a lower incidence of opioid-related adverse events than bupivacaine HCl and placebo. Although additional data would be beneficial, current evidence indicates that bupivacaine/meloxicam PR is a promising non-opioid treatment option for the management of postoperative pain. Plain Language Summary Poorly managed pain after surgery can lead to decreased quality of life, longer recovery time and a higher risk of complications. Perioperative local anaesthetics are commonly used to manage postoperative pain, but these drugs have a short duration of action. Bupivacaine/meloxicam PR (Zynrelef(R)) is a long-acting FDC of the local anaesthetic bupivacaine and the NSAID meloxicam approved for the treatment of postoperative pain. Following application without a needle into the surgical site, the active ingredients are simultaneously released for approximate to 3 days. Bupivacaine/meloxicam PR significantly reduced postoperative pain and opioid consumption and increased the proportion of opioid-free patients following bunionectomy, herniorrhaphy and TKA. When used as the foundation of a scheduled non-opioid MMA regimen, bupivacaine/meloxicam PR further reduced pain and the need for opioids. Bupivacaine/meloxicam PR had a similar tolerability profile to those of bupivacaine hydrochloride and placebo, with a lower incidence of opioid-related adverse events. Bupivacaine/meloxicam PR is a promising non-opioid treatment option for managing postoperative pain.

Automated summary

Bupivacaine/meloxicam PR is a promising non-opioid treatment option for postoperative pain management, showing significant reduction in pain and opioid consumption. It has a favorable tolerability profile and can be used as part of a scheduled non-opioid multimodal analgesia regimen to further improve pain control. Additional data would be beneficial to further support its efficacy.