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Publications

Acute Care

ZYNRELEF®

Gwo-Chin Lee, MD1 Richard Berkowitz, MD2 Scott Hacker, MD3 Jia Hu, PhD4 Alan Rechter, MD5, “HTX-011 in Combination with Multimodal Analgesic Regimen Minimized Severe Pain and Opioid Use after Total Knee Arthroplasty in an Open-Label Study.” June 10, 2022.

Opioid-Free Recovery After Hernia Repair With HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting. Pain and Therapy, published online, July 27, 2021

Tina Yip, Jia Hu, Pamela S Hawn, Amy Yamamoto & Gary Oderda, HTX-011 effectively reduces postoperative pain intensity and opioid use in the elderly. Published online July 21, 2021, Pain Management.

Brummett C, Evans-Shields J, England C, Kong AM, Lew CR, Henriques C, Zimmerman N, Sun E. Increased health care costs associated with new persistent opioid use after major surgery in opioid-naive patients. J Manag Care Spec Pharm. 2021 Feb 24;1-12. doi: 10.18553/jmcp.2021.20507

Pollak R, Cai D, Gan TJ. 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. doi: 10.7547/20-204.

Goudra B, Singh N, Xue L, Goyal A, Gouda D, Singh PM. Efficacy of new long acting bupivacaine HTX 011 in providing pain relief for patients undergoing elective surgery – a meta analysis of prospective randomized controlled trials. Anesth Essays Res. 2020;14(2):288-294.

Singla N, Winkle P, Bertoch T, Hu J, Beaton A, Redan J. Opiod-free recovery after herniorrhaphy with HTX-011 as the foundation of a multimodal analgesic regimen. Surgery. doi: 10.1016/j.surg.2020.06.036.

Lachiewicz PF, Lee G-C, Pollak RA, Leiman DG, Hu J, Sah AP. HTX-011 reduced pain and opioid use after primary total knee arthroplasty: results of a randomized phase 2b trial. J Arthroplasty. doi: https://doi.org/10.1016/j.arth.2020.05.044.

Ottoboni T, Quart B, Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. 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.

Viscusi E, Minkowitz H, Winkle P, Ramamoorthy S, Hu J, Singla N. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study. Hernia. doi: 10.1007/s10029-019-02023-6.

Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee G-C. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: Phase 3 results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019;44:700-706.

Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006;53(3):98-108.

Oncology Care

CINVANTI®

Schwartzberg, L.S., Navari, R.M. Safety of Polysorbate 80 in the Oncology Setting. Adv Ther 35, 754–767 (2018).

Dranitsaris, G., Moezi, M., Dobson, K. et al. A real-world study to evaluate the safety and efficacy of three injectable neurokinin-1 receptor antagonist formulations for the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Support Care Cancer 30, 6649–6658 (2022).

Ottoboni, Thomas; Lerner, Laura; Santhouse, Arlene. Stability of Aprepitant Injectable Emulsion in Alternate Infusion Bags, in Refrigerated Storage, and Admixed with Dexamethasone and Palonosetron. Published online in Drug Design, Development and Therapy, June 15, 2021.

Burns D, Kula J, Marshall S, Ashworth E, Ornelas M. Best practice approach to successful conversion of fosaprepitant to aprepitant IV in a large multisite community oncology infusion center: A retrospective analysis. Advances in Therapy. May 23, 2020. doi.org/10.1007/s12325-020-01377-z.

Perry TS, Dickson N, Patton JF. Safety of antiemetic prophylaxis with HTX-019 as a 30-min infusion in patients with cancer: a retrospective study. Future Oncol. doi: 10.2217/fon-2019-0835.

Navari RM, Mosier M. Crossover safety study of aprepitant: 2-minute injection vs 30-minute infusion in cancer patients receiving emetogenic chemotherapy. Onco Targets Ther. 2019;12:3277-3284.

Walton G. Safety profile of HTX-019 administered as an intravenous push in cancer patients: A retrospective review. Adv Ther. 2019;36(3):662-669.

Ottoboni T, Lauw M, Keller MR, Cravets M, Manhard K, Clendeninn N, Quart B. HTX-019 via 2-min injection or 30-min infusion in healthy subjects. Future Oncol. 2019;15(8):865-874.

Navari RM. HTX-019: polysorbate 80- and synthetic surfactant-free neurokinin 1 receptor antagonist for chemotherapy-induced nausea and vomiting prophylaxis. Future Oncol. 2019;15(3):241-255.

Ottoboni T, Lauw M, Keller MR, Cravets M, Manhard K, Clendeninn N, Quart B. Safety of HTX-019 (intravenous aprepitant) and fosaprepitant in healthy subjects. Future Oncol. 2018;14(27):2849-2859.

Navari RM, Schwartzberg LS. Evolving role of neurokinin 1-receptor antagonists for chemotherapy-induced nausea and vomiting. Onco Targets Ther. 2018;11:6459-6478.

Ottoboni T, Keller MR, Cravets M, Clendeninn N, Quart B. Bioequivalence of HTX-019 (aprepitant IV) and fosaprepitant in healthy subjects: a Phase I, open-label, randomized, two-way crossover evaluation. Drug Des Devel Ther. 2018;12:429-435.

SUSTOL®

Schwartzberg LS, Marks SM, Gabrail NY, Geller RB, Kish J. Real-world effectiveness of palonosetron-based antiemetic regimens: preventing chemotherapy-induced nausea and vomiting. J Comp Eff Res. 2019;8(9):657-670.

Erickson R, Nebughr N, Mosier MC, Nibley W. Hydration requirements in patients receiving highly emetogenic chemotherapy. Future Oncol. 2019;15(7):753-761.

Smith C, Smith M, Cunningham R, Davis S. Recent advances in antiemetics: New formulations of 5-HT3 receptor antagonists. Cancer Nursing. January 25, 2019. doi: 10.1097/NCC.0000000000000694.

Vacirca J, Caruana D, Calcanes G, Mosier M, Boccia R, McBride A. Hydration requirements with emetogenic chemotherapy: granisetron extended-release subcutaneous versus palonosetron. Future Oncol. 2018;14(14):1387-1396.

Schnadig ID, Agajanian R, Dakhil C, Gabrail N, Vacirca J, Taylor C, Wilks S, Braun E, Mosier MC, Geller RB, Schwartzberg L, Vogelzang N. APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide–based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the phase III randomized MAGIC trial. Cancer Manag Res. 2017;9:179-187.

Schwartzberg L, Mosier M, Geller RB, Klepper MJ, Schnadig I, Vogelzang NJ. APF530 for nausea and vomiting prevention following cisplatin: phase 3 MAGIC trial analysis. J Community Support Oncol. 2017;15(2):82-88.

Deeks ED. Granisetron extended-release injection: A review in chemotherapy-induced nausea and vomiting. Drugs. 2016;76(18):1779-1786.

Schnadig ID, Agajanian R, Dakhil C, Gabrail NY, Smith RE Jr, Taylor C, Wilks ST, Schwartzberg LS, Cooper W, Mosier MC, Payne JY, Klepper MJ, Vacirca JL. APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy. Future Oncol. 2016;12(12):1469-1481.

Boccia R, O’Boyle E, Cooper W. Randomized phase III trial of APF530 versus palonosetron in the prevention of chemotherapy-induced nausea and vomiting in a subset of patients with breast cancer receiving moderately or highly emetogenic chemotherapy. BMC Cancer. 2016;16(1):166.

Raftopoulos H, Boccia R, Cooper W, O’Boyle E, Gralla RJ. Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria. Future Oncol. 2015;11(18):2541-2551.

Boccia R, Cooper W, O’Boyle E. Sustained antiemetic responses with APF530 (sustained-release granisetron) during multiple cycles of emetogenic chemotherapy. J Community Support Oncol. 2015;3(2):38-46.

Ottoboni T, Gelder MS, O’Boyle E. Biochronomer™ technology and the development of APF530, a sustained release formulation of granisetron. J Exp Pharmacol. 2014;6:15-21.

Raftopoulos H, Cooper W, O’Boyle E, Gabrail N, Boccia R, Gralla RJ. Comparison of an extended-release formulation of granisetron (APF530) versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: results of a prospective, randomized, double-blind, noninferiority phase 3 trial. Support Care Cancer. 2015;23(3):723-732.

Gabrail N, Yanagihara R, Spaczyński M, Cooper W, O’Boyle E, Smith C, Boccia R. Pharmacokinetics, safety, and efficacy of APF530 (extended-release granisetron) in patients receiving moderately or highly emetogenic chemotherapy: results of two phase 2 trials. Cancer Manag Res. 2015;7:83-92.

Mason JW, Moon TE, O’Boyle E, Dietz A. A randomized, placebo-controlled, four-period crossover, definitive QT study of the effects of APF530 exposure, high-dose intravenous granisetron, and moxifloxacin on QTc prolongation. Cancer Manag Res. 2014;6:181-190.

Polymer Technology

Biochronomer®

Heller J, Barr J. Biochronomer technology. Expert Opin Drug Deliv. 2005;2(1):169-183.

Heller J, Barr J. Poly(ortho esters)—from concept to reality. Biomacromolecules. 2004;5(5):1625-1632.

Heller J, Barr J, Ng SY, Abdellauoi KS, Gurny R. Poly(ortho esters): synthesis, characterization, properties and uses. Adv Drug Deliv Rev. 2002;54(7):1015-1039.

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