MicroDose Therapeutx Inc. today announced that its collaborators at the University of Pittsburgh (Pitt) have completed a Phase I study at the University of Pittsburgh Medical Center with atropine sulfate delivered from the MicroDose proprietary dry powder inhaler (DPI). The study is a further step in MicroDose's development of an atropine inhaler to treat nerve agent poisoning targeted for military and civil defense applications. Results of the study will be presented by Pitt and MicroDose at the 18th Congress of the International Society for Aerosols in Medicine in Rotterdam, June 19-22. The U.S. Department of Defense Chemical Biological Medical Systems Joint Project Management Office manages the contract awarded to Pitt to conduct studies of this potential treatment for the effects, including bronchopulmonary symptoms, of mild to moderate organophosphorus poisoning after adequate amounts of injectable atropine have been administered.
The Phase 1 clinical trial was an open-label, active-controlled, crossover, safety study investigating the pharmacokinetics of atropine dry powder inhalation in 17 adult healthy subjects. The trial compared multiple inhalations of an atropine dry powder with one dose of a commercially marketed atropine intramuscular (IM) injection. The primary endpoint of the trial was pharmacokinetic comparison between inhaled and intramuscular atropine over 12 hours. Pitt researchers conducted the study using a device manufactured by subcontractor MicroDose Defense Products, LLC., a majority-owned subsidiary of MicroDose Therapeutx, Inc.
"Follow-up trials will further demonstrate our ability to achieve very high atropine bioavailability from the MicroDose inhaler (85%, relative to IM atropine) to attain both local and systemic signs of atropinization," said Robert O. Cook, Ph.D., Senior Director, Product Commercialization Group, at MicroDose. "While intramuscular injection of atropine is a recognized treatment for acute poisoning, the inhaled route offers a non-invasive alternative by delivering atropine directly to the lungs where local complications present, which may be more convenient when repeated dosings are required."
Principal investigator, Tim Corcoran, Ph.D., Assistant Professor of medicine and bioengineering at Pitt, said, "It is a unique application of an aerosolized medication in that it provides both treatment of the lungs locally, as well as a means of delivering drug systemically to the bloodstream. The inhaler could provide substantial and consistent systemic dosing rapidly after administration."
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