HALOZYME, BAXTER REPORT DATA ON HYLENEX, MORPHINE COMBINATION

Halozyme Therapeutics and Baxter Healthcare announced the presentation of 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 percent versus morphine with placebo, and appeared to be safe and well tolerated.

"The observed shortening of the time to maximal concentration for a co-administered morphine with Hylenex recombinant implies that clinical effects, such as analgesia, may be achieved more rapidly by subcutaneous injection, without the need for intravenous infusion," Jay Thomas, principal investigator, said.

Hylenex recombinant is a liquid injectable formulation that includes the active pharmaceutical ingredient, recombinant human hyaluronidase, which is FDA-approved for use as a spreading agent to increase the absorption and dispersion of other injected drugs. Morphine is currently approved for both intravenous and subcutaneous administration.

The double-blind, randomized, crossover, placebo-controlled INFUSE 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.