Journal of Pain and Symptom Management
Volume 38, Issue 5 , Pages 663-672 , November 2009

The INFUSE-Morphine Study: Use of Recombinant Human Hyaluronidase (rHuPH20) to Enhance the Absorption of Subcutaneously Administered Morphine in Patients with Advanced Illness

  • 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.
    • ,
  • Mark S. Wallace, MD

      Affiliations

    • Department of Anesthesiology, University of California, San Diego Center for Pain Medicine, San Diego, California, USA
    • ,
  • Richard C. Yocum, MD

      Affiliations

    • Department of Drug Development and Medical Affairs, Rockwell Medical Technologies, Inc., Wixom, Michigan, USA
    • ,
  • Daniel E. Vaughn, PhD

      Affiliations

    • Department of Research and Development, Halozyme Therapeutics, Inc., San Diego, California, 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.

  • Image Result

    Randomized sequence of injections. A, intravenous morphine; B, subcutaneous morphine with placebo; C, subcutaneous morphine with rHuPH20.

    Randomized sequence of injections. A, intravenous morphine; B, subcutaneous morphine with placebo; C, subcutaneous morphine with rHuPH20.

  • Image Result

    Tmax (mean ± SD) and Cmax (geometric mean ± DS) of morphine for each administration method.

    Tmax (mean ± SD) and Cmax (geometric mean ± DS) of morphine for each administration method.

  • Image Result

    Pharmacokinetic curves for morphine plasma concentration over four hours postinjection (population means ± SDs) for each administration method.

    Pharmacokinetic curves for morphine plasma concentration over four hours postinjection (population means ± SDs) for each administration method.

  • Image Result

    Pharmacokinetic curves for morphine plasma concentration over the first 30minutes postinjection (population means ± SDs) for each administration method.

    Pharmacokinetic curves for morphine plasma concentration over the first 30minutes postinjection (population means ± SDs) for each administration method.

  • Image Result

    Morphine AUC0−t (geometric mean +/− DS) for each administration method.

    Morphine AUC0−t (geometric mean +/− DS) for each administration method.

  • Image Result

    Scores for severity of a) injection-site edema, (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe) b) rash (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe), and c) discomfort (0 =

    Scores for severity of a) injection-site edema, (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe) b) rash (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe), and c) discomfort (0 = no discomfort, 100 = worst possible discomfort [100 mm VAS scale]).

 Halozyme Therapeutics, Inc. funded the study. Baxter Healthcare Corporation supported the study with 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.

 At the time 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: NCT00593281.

PII: S0885-3924(09)00727-1

doi: 10.1016/j.jpainsymman.2009.03.009

Journal of Pain and Symptom Management
Volume 38, Issue 5 , Pages 663-672 , November 2009

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