Lantheus Medical Imaging reports new Phase 4 data from DEFINITY study

Lantheus Medical Imaging, Inc.Jun 14 2010

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced new data from a Phase 4, open-label safety study evaluating the effect of DEFINITY^® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, an echocardiography contrast agent, on pulmonary and systemic artery hemodynamics in patients with either normal or increased baseline pulmonary artery pressure. The study demonstrated that administration of DEFINITY^® did not result in any clinically or statistically significant changes in systemic or pulmonary artery hemodynamic measurements in either patient group. The data were presented on Sunday, June 13, 2010, by Kevin Wei, M.D., Associate Professor of Medicine at Oregon Health & Science University, during the "Contrast Perfusion Imaging in Decision-Making" case-based presentation at the American Society of Echocardiography 21^st Annual Scientific Sessions in San Diego.

“This Phase 4 safety study marks Lantheus' third and final post-approval, FDA-required safety study for DEFINITY®, and illustrates that DEFINITY® can be used in patients with or without pulmonary hypertension when contrast is needed to enhance suboptimal echocardiograms.”

"Examining changes in pulmonary pressures following the administration of ultrasound contrast imaging agents is an important safety measurement," said Dr. Wei. "This Phase 4 safety evaluation demonstrated that the administration of DEFINITY^® produced no changes in pulmonary or systemic hemodynamic parameters, either in patients with normal or increased pulmonary artery pressure at baseline, providing further validation of the safety profile of this agent."

The primary objective of this study was to evaluate the effect of DEFINITY^® on pulmonary artery hemodynamics in patients with normal or elevated baseline pulmonary artery pressure who were undergoing right heart catheterization as part of routine clinical evaluation. The study's secondary objective was to assess the safety and potential immunologic effects of DEFINITY^® administration in these patients.