Journal of Pain and Symptom Management
Volume 38, Issue 5 , Pages 673-682 , November 2009

The INFUSE-Morphine IIB Study: Use of Recombinant Human Hyaluronidase (rHuPH20) to Enhance the Absorption of Subcutaneous Morphine in Healthy Volunteers

  • Jay R. Thomas, MD, PhD

      Affiliations

    • Department of Supportive Care Medicine, City of Hope, Duarte, California, USA
    • Corresponding Author InformationAddress correspondence to: Jay R. Thomas, MD, PhD, City of Hope, 1500 East Duarte Road, Machris 1111, Duarte, CA 91010-3000, USA.
    • ,
  • Richard C. Yocum, MD

      Affiliations

    • Department of Drug Development and Medical Affairs, Rockwell Medical Technologies, Inc., Wixom, Michigan, USA
    • ,
  • Michael F. Haller, PhD

      Affiliations

    • Department of Research and Development, Halozyme Therapeutics, Inc., San Diego, California, USA
    • ,
  • Jocelyne Flament, MD

      Affiliations

    • European Organisation for Research and Treatment of Cancer AISBL-IVZW, Brussels, Belgium

,Accepted 1 April 2009.

References 

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  2. Hussain NA, Warshaw G. Utility of clysis for hydration in nursing home residents. J Am Geriatr Soc. 1996;44:969–973
  3. Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007;4:427–440
  4. Elsner F, Radbruch L, Loick G, Gartner J, Sabatowski R. Intravenous versus subcutaneous morphine titration in patients with persisting exacerbation of cancer pain. J Palliat Med. 2005;8:743–750
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  9. Kurul S, Saip P, Aydin T. Totally implantable venous-access ports: local problems and extravasation injury. Lancet Oncol. 2002;3:684–692
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  13. Yocum RC, Kennard D, Heiner LS. Assessment and implication of the allergic sensitivity to a single dose of recombinant human hyaluronidase injection: a double-blind, placebo-controlled clinical trial. J Infus Nurs. 2007;30:293–299
  14. Thomas JR, Yocum RC, Haller MF, von Gunten CF. Assessing the role of human recombinant hyaluronidase in gravity-driven subcutaneous hydration: the INFUSE-LR study. J Palliat Med. 2007;10:1312–1320
  15. Pirrello RD, Ting Chen C, Thomas SH. Initial experiences with subcutaneous recombinant human hyaluronidase. J Palliat Med. 2007;10:861–864
  16. Stuart-Harris R, Joel SP, McDonald P, Currow D, Slevin ML. The pharmacokinetics of morphine and morphine glucuronide metabolites after subcutaneous bolus injection and subcutaneous infusion of morphine. Br J Clin Pharmacol. 2000;49:207–214
  17. Morsman CD, Holden R. The effects of adrenaline, hyaluronidase and age on peribulbar anaesthesia. Eye. 1992;6(Pt 3):290–292
  18. Roberts JE, MacLeod BA, Hollands RH. Improved peribulbar anaesthesia with alkalinization and hyaluronidase. Can J Anaesth. 1993;40:835–838
  19. Sarvela J, Nikki P. Hyaluronidase improves regional ophthalmic anaesthesia with etidocaine. Can J Anaesth. 1992;39:920–924
  20. Nathan N, Benrhaiem M, Lotfi H, et al. The role of hyaluronidase on lidocaine and bupivacaine pharmacokinetics after peribulbar blockade. Anesth Analg. 1996;82:1060–1064

 Halozyme Therapeutics, Inc. funded the study. Baxter Healthcare Corporation supported the study with study documents, database, and statistical analysis. Editorial assistance in the preparation of this manuscript was provided by Barbara J. Goldman, RPh, of Advogent, and funded by Baxter.

 When the study was conducted, Dr. Flament was employed by Baxter Healthcare Corporation, Deerfield, IL, and Dr. Yocum was employed by Halozyme Therapeutics, Inc. San Diego, CA.

 Clinical Trial Registration: www.ClinicalTrials.gov, Identifier: NCT 00311519.

PII: S0885-3924(09)00728-3

doi: 10.1016/j.jpainsymman.2009.03.010

Journal of Pain and Symptom Management
Volume 38, Issue 5 , Pages 673-682 , November 2009

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