Baxter Healthcare Corporation announced results of a Phase I study that evaluated pulmonary insulin produced with Baxter's PROMAXX microsphere technology and administered using a small, standard dry powder inhaler.
Baxter presented the Phase I data earlier this week at the Respiratory Drug Delivery Europe 2007 Conference in Paris.
The study demonstrates that the insulin powder can be effectively administered to the deep lung using an off-the-shelf dry powder inhaler designed for upper airway drug delivery. A total of 30 subjects participated in the randomized, two-way crossover study conducted in Germany. Each subject received in randomized fashion a single dose of 10 International Units of insulin through subcutaneous injection (SC) in one period, and 6.5 milligrams of the inhaled insulin microspheres, called recombinant human insulin inhalation powder (RHIIP) in the other period.
RHIIP is made using Baxter's proprietary PROMAXX formulation technology. Unlike other dry powder formulations of insulin, RHIIP is 95 percent insulin and does not rely on the use of inactive ingredients to facilitate delivery to the deep lung. In this study, no serious adverse events were reported and no subjects withdrew from the study due to an adverse event. All adverse events were mild in severity. The most common reported treatment-emergent adverse event was phlebitis. There were no reported episodes of cough or shortness of breath in this study.