MicroDose Therapeutx Inc. (formerly MicroDose Technologies) today announced that it has initiated 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 the development program for an atropine inhaler to treat nerve agent poisoning in military and civil defense applications. The program is being congressionally funded and managed through the Chemical Biological Medical Systems Joint Project Management Office to treat the symptoms, including bronchopulmonary, of mild to moderate organophosphorus poisoning after adequate amounts of injectable atropine have been administered.
The Phase 1 clinical trial is an open-label, active-controlled, crossover, safety study investigating the pharmacokinetics of atropine dry powder inhalation in 18 adult healthy subjects. The trial compares multiple inhalations of an atropine dry powder with one dose of a commercially marketed atropine intramuscular injection. The primary endpoint of the trial is the pharmacokinetic comparison between inhaled and intramuscular atropine over 12 hours.
This study represents the third U.S. clinical trial involving the MicroDose DPI to be initiated within the last 14 months. The study is being conducted through a majority-owned subsidiary, MicroDose Defense Products, LLC.
“We are pleased to announce first patient dosing has taken place at the University of Pittsburgh with our advanced dry powder inhaler,” 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.”