HTX-011 Effectively Reduces Postoperative Pain Intensity and Opioid use in the Elderly

References

• Falzone E , HoffmannC , KeitaH. Postoperative analgesia in elderly patients. Drugs Aging30(2), 81–90 (2013).
   PubMed Web of Science ®Google Scholar
• Ko FC . Preoperative frailty evaluation: a promising risk-stratification tool in older adults undergoing general surgery. Clin. Ther.41(3), 387–399 (2019).
   PubMed Web of Science ®Google Scholar
• Gan TJ . Poorly controlled postoperative pain: prevalence, consequences, and prevention. J. Pain. Res.10, 2287–2298 (2017).
   PubMed Web of Science ®Google Scholar
• Halaszynski TM . Perioperative pain management in the elderly surgical patient. Univers J. Med. Sci.1(2), 36–49 (2013).
   Google Scholar
• Mckeown JL . Pain management issues for the geriatric surgical patient. Anesthesiol. Clin.33(3), 563–576 (2015).
   PubMedGoogle Scholar
• Oderda GM , SenagoreAJ , MorlandKet al. Opioid-related respiratory and gastrointestinal adverse events in patients with acute postoperative pain: prevalence, predictors, and burden. J. Pain. Palliat. Care Pharmacother.33(3-4), 82–97 (2019).
   PubMed Web of Science ®Google Scholar
• Kessler ER , ShahM , GruschkusSK , RajuA. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy33(4), 383–391 (2013).
   PubMed Web of Science ®Google Scholar
• Oderda G . Challenges in the management of acute postsurgical pain. Pharmacotherapy32(Suppl. 9), S6–S11 (2012).
   Web of Science ®Google Scholar
• Rajan J , BehrendsM. Acute pain in older adults: recommendations for assessment and treatment. Anesthesiol. Clin.37(3), 507–520 (2019).
   PubMedGoogle Scholar
• Clegg A , YoungJB. Which medications to avoid in people at risk of delirium: a systematic review. Age. Ageing40(1), 23–29 (2011).
   PubMed Web of Science ®Google Scholar
• Leung JM , SandsLP , LimE , TsaiTL , KinjoS. Does preoperative risk for delirium moderate the effects of postoperative pain and opiate use on postoperative delirium?Am. J. Geriatr. Psychiatry21(10), 946–956 (2013).
   PubMed Web of Science ®Google Scholar
• Rudolph JL , MarcantonioER. Review articles: postoperative delirium: acute change with long-term implications. Anesth. Analg.112(5), 1202–1211 (2011).
   PubMed Web of Science ®Google Scholar
• Strom C , RasmussenLS , SieberFE. Should general anaesthesia be avoided in the elderly?Anaesthesia69(Suppl. 1), 35–44 (2014).
   PubMed Web of Science ®Google Scholar
• ZYNRELEF™, prescribing information. Heron Therapeutics, Inc., CA, USA (2021).
   Google Scholar
• Balocco AL , Van ZundertPGE , GanSS , GanTJ , HadzicA. Extended release bupivacaine formulations for postoperative analgesia: an update. Curr. Opin. Anaesthesiol.31(5), 636–642 (2018).
   PubMed Web of Science ®Google Scholar
• Ottoboni T , QuartB , PawasauskasJ , DastaJF , PollakRA , ViscusiER. Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Reg. Anesth. Pain. Med. doi:10.1136/rapm-2019-100714 (2019) ( Epub ahead of print).
   PubMed Web of Science ®Google Scholar
• Viscusi E , GimbelJS , PollackRA , HuJ , LeeGC. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study. Reg. Anesth. Pain. Med. doi:10.1136/rapm-2019-100531 (2019) ( Epub ahead of print).
   Web of Science ®Google Scholar
• Hardman D , LukeCB , SalehJ , OttoboniT. HTX-011: predictable release rates of bupivacaine and meloxicam for 72 hours. Presented at: Anesthiesiology 2020.2–5 October 2020.
   Google Scholar
• Marcaine®, prescribing information. Hospira, Inc., IL, USA (2011).
   Google Scholar
• Mobic®, package insert. Boehringer Ingelheim Pharmaceuticals, Inc., CT, USA (2016).
   Google Scholar
• Viscusi E , MinkowitzH , WinkleP , RamamoorthyS , HuJ , SinglaN. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the Phase III EPOCH 2 study. Hernia23(6), 1071–1080 (2019).
   PubMed Web of Science ®Google Scholar
• Exparel®, prescribing information. Pacira Pharmaceuticals, CA, USA (2018).
   Google Scholar
• Xaracoll®, prescribing information. Innocoll Pharmaceuticals Limited, Athlone, Ireland (2020).
   Google Scholar
• Aubrun F , MarmionF. The elderly patient and postoperative pain treatment. Best Pract. Res. Clin. Anaesthesiol.21(1), 109–127 (2007).
   PubMedGoogle Scholar
• US Food and Drug Administration . FDA Drug Safety Communication: FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class. Includes potential for abuse, addiction, and other serious risks. (2020). https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class
   Google Scholar
• Lachiewicz PF , LeeGC , PollakRA , LeimanDG , HuJ , SahAP. HTX-011 reduced pain and opioid use after primary total knee arthroplasty: results of a randomized phase 2b trial. J. Arthroplasty35(10), 2843–2851 (2020).
   PubMed Web of Science ®Google Scholar
• Luke C , SalehJ , HardmanD , OttoboniT. HTX-011: predictable release rates of bupivacaine and meloxicam for 72 hours. Presented at: American Society of Regional Anesthesia and Pain Medicine (ASRA) Worldwide 2020: 19th Annual Pain Medicine Meeting.19–22 November 2020.
   Google Scholar
• Pollak R , CaiD , GanTJ. Opioid-free recovery from bunionectomy with HTX-011, a dual-acting local anesthetic combining bupivacaine and meloxicam, as the foundation of non-opioid multimodal analgesia. J. Am. Podiatr. Med. Assoc.111(3), Article_15 (2021).
   PubMed Web of Science ®Google Scholar
• Singla N , WinkleP , BertochT , HuJ , BeatonA , RedanJ. Opioid-free recovery after herniorrhaphy with HTX-011 as the foundation of a multimodal analgesic regimen. Surgery168(5), 915–920 (2020).
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration . Draft Guidance for Industry on Analgesic Indications: Developing Drug and Biological Products; Availability [Docket No. FDA-2014-D-0091]. (2014). https://www.federalregister.gov/documents/2014/02/06/2014-02557/draft-guidance-for-industry-on-analgesic-indications-developing-drug-and-biological-products
   Google Scholar