Acusphere & FDA agree on CAD drug trial
Specialty pharmaceutical company Acusphere has reached an agreement with the FDA on a Special Protocol Assessment (SPA) clinical trial to assess the ability of the company’s Imagify drug to detect coronary artery disease (CAD) on stress ultrasound.
The non-binding SPA agreement should set in motion a Phase 3 clinical trial of Acusphere’s Imagify Perflubutane Polymer Microspheres for Injectable Suspension, which would compare the drug’s detection of CAD on stress ultrasound with normal stress ultrasound.
According to Lexington, Mass.-based Acusphere, the trial would enroll 900 patients and cost approximately $15 million, providing the company and investors greater confidence of new drug approval if Imagify satisfies the agreed-upon protocols, achieves the clinical endpoints and provides a favorable risk benefit profile.
The non-binding SPA agreement should set in motion a Phase 3 clinical trial of Acusphere’s Imagify Perflubutane Polymer Microspheres for Injectable Suspension, which would compare the drug’s detection of CAD on stress ultrasound with normal stress ultrasound.
According to Lexington, Mass.-based Acusphere, the trial would enroll 900 patients and cost approximately $15 million, providing the company and investors greater confidence of new drug approval if Imagify satisfies the agreed-upon protocols, achieves the clinical endpoints and provides a favorable risk benefit profile.