Acusphere Inc. Reaches Special Protocol Assessment Agreement with FDA for Imagify(TM) Phase 3 Placebo-Controlled Trial
Published: Jun 08, 2011
LEXINGTON, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (ACUS.PK), a specialty pharmaceutical company, today announced that it had reached an agreement with the U.S. Food & Drug Administration (FDA) regarding the design of a new Phase 3 study of the company’s lead product candidate, Imagify™ Perflubutane Polymer Microspheres for Injectable Suspension. As previously announced, this new study, designed under the Special Protocol Assessment (SPA) process, will compare stress ultrasound with Imagify to stress ultrasound without Imagify for the detection of coronary artery disease (CAD).