ArticleRegional anesthesia and pain medicine2019
Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain.
Article in Regional anesthesia and pain medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02762929 (A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011, HTX-002, or HTX-009 for Postoperative Analgesia Following Bunionectomy), which is not on this map. Cited by 24 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011, HTX-002, or HTX-009 for Postoperative Analgesia Following Bunionectomy
Who cites it
24 citing papers in PubMed, 51 citations in OpenAlex.
- Differentiating Normal Healing From Infection in Total Joint Arthroplasty: An Educational and Diagnostic Tool for Emergency Providers Evaluating the Postoperative Patient.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026Review
- Sustained-release local anesthetics: advances in drug delivery systems for prolonged postoperative analgesia.Anesthesia and pain medicine · 2026Review
- Liposomal bupivacaine for postoperative analgesia after thoracoscopic surgery: a systematic review and meta-analysis.Journal of thoracic disease · 2026Article
- Precision and pitfalls: evolving role of ultrasound-guided nerve blocks in Orthopedic perioperative pathway-a perspective.Frontiers in medicine · 2026Article
- New Gel Approaches for the Transdermal Delivery of Meloxicam.Gels (Basel, Switzerland) · 2025Review
- A Novel Extended-Release Analgesic Without Periarticular Injection Provides Inferior Immediate Postsurgical Pain Relief in Total Hip and Knee Arthroplasty Patients.Arthroplasty today · 2025Article
- Intradermally injected abobotulinumtoxinA administered preemptively before surgery alleviates post-surgical pain and normalizes behavior in a translational animal model.Scientific reports · 2025Article
- Drugs in Development to Manage Acute Pain.Drugs · 2025Review
- A carrier-free long-acting ropivacaine formulation using methylprednisolone sodium succinate as a dual-functional adjuvant.Theranostics · 2025Article
- Advances in the use of local anesthetic extended-release systems in pain management.Drug delivery · 2024Review
- Extended Release of Bupivacaine from Temperature-Responsive PNDJ Hydrogels Improves Postoperative Weight-Bearing in Rabbits Following Knee Surgery.Pharmaceuticals (Basel, Switzerland) · 2024Article
- The Efficacy of Liposomal Bupivacaine in Thoracic Surgery: A Systematic Review and Meta-Analysis.Journal of pain research · 2024Review
- Pharmacokinetics, metabolite profiling, safety and tolerability of YZJ-4729 tartrate, a novel G protein-biased μ-opioid receptor agonist, in healthy Chinese subjects.Frontiers in pharmacology · 2023Article
- Safety and Efficacy of ZynrelefJournal of pain & relief · 2023Article
- Combination anesthetic therapy: co-delivery of ropivacaine and meloxicam using transcriptional transactivator peptide modified nanostructured lipid carriersDrug delivery · 2022Article
- Addressing the Needs of the Rapidly Aging Society through the Development of Multifunctional Bioactive Coatings for Orthopedic Applications.International journal of molecular sciences · 2022Review
- The Opioid Epidemic in the Age of the COVID-19 Pandemic.Aesthetic surgery journal · 2022Article
- Newer, Longer Acting Local Anesthetics: The future of postoperative pain management looks bright.Sultan Qaboos University medical journal · 2022Article
- A guide to regional analgesia for Total Knee Arthroplasty.EFORT open reviews · 2021Article
- Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study.Pain and therapy · 2021Article
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Authors and funding
6 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesObtaining consistent efficacy beyond 12-24 hours with local anesthetics, including extended-release formulations, has been a challenging goal. Inflammation resulting from surgery lowers the pH of affected tissues, reducing neuronal penetration of local anesthetics. HTX-011, an investigational, nonopioid, extended-release dual-acting local anesthetic combining bupivacaine and low-dose meloxicam, was developed to reduce postsurgical pain through 72 hours using novel extended-release polymer technology. Preclinical studies and a phase II clinical trial were conducted to confirm the mechanism of action of HTX-011.
methodsIn a validated postoperative pain pig model and a phase II bunionectomy trial, the analgesic effects of HTX-011, oral meloxicam (preclinical only), liposomal bupivacaine (preclinical only) and saline placebo were evaluated. The optimal meloxicam:bupivacaine ratio for HTX-011 and the effect of HTX-011 on incisional tissue pH were also evaluated preclinically.
resultsPreclinical data demonstrate the ability of HTX-011 to address local tissue inflammation as demonstrated by a less acidic tissue pH, which was associated with potentiated and prolonged analgesic activity. In the phase II bunionectomy study, HTX-011 achieved superior and sustained pain relief through 72 hours after surgery compared with each component in the polymer.
conclusionsPreclinical animal and clinical results confirm that the low-dose meloxicam in HTX-011 normalizes the local pH in the incision, resulting in superior and synergistic analgesic activity compared with extended-release bupivacaine. HTX-011 represents an extended-release local anesthetic with a dual-acting mechanism of action that may provide an important advancement in the treatment of postoperative pain. TRIAL REGISTRATION NUMBER: NCT02762929.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.