Publications

Chemotherapy-Induced Nausea and Vomiting (CINV)

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 May 9. [Epub ahead of print].

Smith C, Smith M, Cunningham R, Davis S. Recent advances in antiemetics: New formulations of 5-HT3 receptor antagonists. Cancer Nursing. 2019 Jan 25. [Epub ahead of print].

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

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.

CINVANTI®

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.

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, 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.

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.

Pain Management

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;0:1–7. doi:10.1136/rapm-2019-100531.

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. [Published online ahead of print August 19, 2019] Hernia. doi: 10.1007/s10029-019-02023-6.

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

Biochronomer® Technology

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.