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Halozyme, Baxter Get Promising Morphine Study Results

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Halozyme Therapeutics, Inc. and Baxter Healthcare achieved positive results from a Phase IIIB trial showing that subcutaneous administration of morphine with Hylenex recombinant (hyaluronidase human injection) accelerated the time to maximal blood levels of morphine by 33% versus morphine with placebo. The formulation also appeared to be safe and well tolerated.

Hylenex recombinant is a liquid injectable formulation that includes the API, recombinant human hyaluronidase (rHuPH20), which is approved by the FDA for use as a spreading agent to increase the absorption and dispersion of other injected drugs and for subcutaneous (SC) hydration. Morphine is a widely used drug for pain management and is currently approved for both intravenous and subcutaneous administration.

The double-blind, randomized, crossover, placebo-controlled, INFUSE- Morphine study, was designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex recombinant, to determine the time to maximal blood levels after intravenous administration of morphine, and to assess safety and tolerability.

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