HTX-011 (Bupivacaine and Meloxicam) for the Prevention of Postoperative Pain – Clinical Considerations

Cornett, Elyse M.; Turpin, Michelle A. Carroll; Busby, Matthew; Pham, Alex D.; Kallurkar, Anusha; Brondeel, Kimberley C.; Schoonover, John; Arulkumar, Sailesh; Kaye, Alan D.

doi:10.2217/pmt-2020-0097

Cited by 8 publications

(7 citation statements)

References 31 publications

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“…For use as a local anesthetic by wound infiltration, liposomal bupivacaine (LB) may reduce opioid use and hospital LOS as well as promote earlier oral diet [ 71 , 72 , 73 ], but this effect may be procedure-specific [ 74 ]. Currently, while evidence exists for the use of IV ketorolac, a non-selective cyclooxygenase (COX) enzyme inhibitor, as a safe and effective component of multimodal analgesia [ 75 , 76 ], data are emerging to support the use of IV and topically applied meloxicam in postoperative medication management based on its longer half-life and cyclooxygenase-2 only inhibition [ 77 , 78 ]. Additionally, use of metamizole (dipyrone) as a unique analgesic with a mechanism mediated through non-COX enzymatic inhibition of prostaglandin E2 formation, is widely employed in Europe for postoperative pain [ 79 , 80 , 81 ].…”

Section: Resultsmentioning

confidence: 99%

Positive Patient Postoperative Outcomes with Pharmacotherapy: A Narrative Review including Perioperative-Specialty Pharmacist Interviews

Parrish

Bodenstab²,

Carneal

et al. 2022

JCM

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The influence of pharmacotherapy regimens on surgical patient outcomes is increasingly appreciated in the era of enhanced recovery protocols and institutional focus on reducing postoperative complications. Specifics related to medication selection, dosing, frequency of administration, and duration of therapy are evolving to optimize pharmacotherapeutic regimens for many enhanced recovery protocolized elements. This review provides a summary of recent pharmacotherapeutic strategies, including those configured within electronic health record (EHR) applications and functionalities, that are associated with the minimization of the frequency and severity of postoperative complications (POCs), shortened hospital length of stay (LOS), reduced readmission rates, and cost or revenue impacts. Further, it will highlight preventive pharmacotherapy regimens that are correlated with improved patient preparation, especially those related to surgical site infection (SSI), venous thromboembolism (VTE), nausea and vomiting (PONV), postoperative ileus (POI), and emergence delirium (PoD) as well as less commonly encountered POCs such as acute kidney injury (AKI) and atrial fibrillation (AF). The importance of interprofessional collaboration in all periprocedural phases, focusing on medication management through shared responsibilities for drug therapy outcomes, will be emphasized. Finally, examples of collaborative care through shared mental models of drug stewardship and non-medical practice agreements to improve operative throughput, reduce operative stress, and increase patient satisfaction are illustrated.

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Section: Resultsmentioning

confidence: 99%

Positive Patient Postoperative Outcomes with Pharmacotherapy: A Narrative Review including Perioperative-Specialty Pharmacist Interviews

Parrish

Bodenstab²,

Carneal

et al. 2022

JCM

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“…34 If a polymeric solution containing PLGA is warranted, the addition of a potent glucocorticoid or other anti-inflammatory agent could be considered both from a pharmacodynamic, pharmacokinetic and tolerability perspective. 8,25…”

Section: Local Adverse Eventsmentioning

confidence: 99%

“…[4][5][6] Three extendedrelease formulations of LAs have been approved by the medical authorities (FDA and/or EMA): a liposomeencapsulated bupivacaine product, 7 a carbohydrate formulation, sucrose acetate isobutyrate (SABER) containing 12% bupivacaine 5 and a dual-acting formulation consisting of bupivacaine (2.6%) and meloxicam (0.2%). 8 The duration of postoperative pain relief for these formulations has been reported to be 48-72 h, although the clinical significance has recently been questioned. 9,10 The present study investigated a novel extended-release LA (LIQ865; Liquidia Technologies, Morrisville, NC, USA).…”

Section: Introductionmentioning

confidence: 99%

Dose safety and pharmacodynamics of subcutaneous bupivacaine in a novel extended‐release microparticle formulation: A phase 1, dose‐ascending study in male volunteers

Jensen,

Bøgevig,

Balchen

et al. 2024

Basic Clin Pharma Tox

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A novel microparticle‐based extended‐release local anaesthetic containing a bupivacaine/poly‐lactic‐co‐glycolic acid (PLGA; LIQ865A) or plain bupivacaine (LIQ865B) was examined in a first‐in‐human trial. The objectives were to examine the dose safety/tolerability and pharmacodynamics. Randomized subcutaneous injections of LIQ865A (n = 16) or LIQ865B (n = 12) and diluent, contralaterally, were administered in a dose‐ascending manner (150‐ to 600‐mg bupivacaine). Subjects were admitted 24 h post‐injection and followed for 30 days post‐injection. The risk ratios (RRs; 95% CI) of erythematous reactions for LIQ865A versus diluent was 9.00 (1.81–52.23; P = 0.006) and for LIQ865B versus diluent 2.50 (0.69–9.94; P = 0.37). The RR for the development of hematomas (LIQ865A versus diluent) were 3.25 (1.52–8.16; P = 0.004) and 4.00 (0.72–24.89; P = 0.32) (LIQ865B versus diluent). Subcutaneous indurations persisting for 4–13 weeks were seen in 6/16 subjects receiving LIQ865A. One subject receiving LIQ865A (600‐mg bupivacaine) developed intermittent central nervous system (CNS) symptoms of local anaesthetic systemic toxicity (85 min to 51 h post‐injection) coinciding with plasma peak bupivacaine concentrations (490–533 ng/ml). Both LIQ865 formulations demonstrated dose‐dependent hypoesthesia and hypoalgesia. The duration of analgesia ranged between 37 and 86 h. The overall number of local adverse events, however, prohibits clinical application without further pharmacological modifications.

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“…Recently, the FDA approved the use of Zynrelef™ (Heron Therapeutics) that provides 72-h release of bupivacaine-meloxicam using a polydioxanone polymer carrier [ 59 ] and of XaraColl® (Innocoll Pharmaceuticals), which is a non-injectable collagen implant containing bupivacaine, for 24 h of pain relief after hernia surgery [ 60 , 61 ]. These novel biomaterial-based pain management formulations significantly reduced post-operative pain and opioid use in patients undergoing bunionectomy, herniorrhaphy, or total knee arthroplasty [ 62 ].…”

Section: Pain Management Biomaterialsmentioning

confidence: 99%

Biomaterials and Regenerative Medicine in Pain Management

Turpin

Romero-Ortega

2022

Curr Pain Headache Rep

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Purpose of Review Pain presents a unique challenge due to the complexity of the biological pathways involved in the pain perception, the growing concern regarding the use of opioid analgesics, and the limited availability of optimal treatment options. The use of biomaterials and regenerative medicine in pain management is being actively explored and showing exciting progress in improving the efficacy of conventional pharmacotherapy and as novel non-pharmacological therapy for chronic pain caused by degenerative diseases. In this paper we review current clinical applications, and promising research in the use of biomaterials and regenerative medicine in pain management. Recent Findings Regenerative therapies have been developed to repair damaged tissues in back, joint, and shoulder that lead to chronic and inflammatory pain. Novel regenerative biomaterials have been designed to incorporate biochemical and physical pro-regenerative cues that augment the efficacy of regenerative therapies. New biomaterials improve target localization with improved tunability for controlled drug delivery, and injectable scaffolds enhance the efficacy of regenerative therapies through improving cellular migration. Advanced biomaterial carrier systems have been developed for sustained and targeted delivery of analgesic agents to specific tissues and organs, showing improved treatment efficacy, extended duration of action, and reduced dosage. Targeting endosomal receptors by nanoparticles has shown promising anti-nociception effects. Biomaterial scavengers are designed to remove proinflammatory reactive oxygen species that trigger nociceptors and cause pain hypersensitivity, providing a proactive approach for pain management. Summary Pharmacotherapy remains the method of choice for pain management; however, conventional analgesic agents are associated with adverse effects. The relatively short duration of action when applied as free drug limited their efficacy in postoperative and chronic pain treatment. The application of biomaterials in pain management is a promising strategy to improve the efficacy of current pharmacotherapy through sustained and targeted delivery of analgesic agents. Regenerative medicine strategies target the damaged tissue and provide non-pharmacological alternatives to manage chronic and inflammatory pain. In the future, the successful development of regenerative therapies that completely repair damaged tissues will provide a more optimal alternative for the treatment of chronic pain caused. Future studies will leverage on the increasing understanding of the molecular mechanisms governing pain perception and transmission, injury response and tissue regeneration, and the development of new biomaterials and tissue regenerative methods.

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HTX-011 (Bupivacaine and Meloxicam) for the Prevention of Postoperative Pain – Clinical Considerations

Cited by 8 publications

References 31 publications

Positive Patient Postoperative Outcomes with Pharmacotherapy: A Narrative Review including Perioperative-Specialty Pharmacist Interviews

Positive Patient Postoperative Outcomes with Pharmacotherapy: A Narrative Review including Perioperative-Specialty Pharmacist Interviews

Dose safety and pharmacodynamics of subcutaneous bupivacaine in a novel extended‐release microparticle formulation: A phase 1, dose‐ascending study in male volunteers

Biomaterials and Regenerative Medicine in Pain Management

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