MGI Pharma initiates Ph III Aquavan program

MGI Pharma, an oncology and acute care-focused US biopharmaceutical company, has inititated a pivotal Phase III program of its investigational injectible sedative Aquavan (fospropofol disodium).

Its late-stage series of evalutaions consists of two randomized, double-blind, multicenter Phase III trials and an open-label safety study. The first evaluation is planned to enroll a total of 300 patients undergoing colonoscopy, while the second will recruit 250 bronchoscopy patients. The endpoints of both trials include sedation and treatment success, patient and investigator satisfaction, as well as measures of sedation adequacy, recovery, clinical benefit and safety.

The Minneapolis-headquartered firm noted that results from its previously-disclosed Phase II dose-ranging study indicated a clear dose response for Aquavan injection and a "promising" therapeutic profile. MGI says it expects patient enrollment to be completed by the end of the year, adding that it plans to submit a New Drug Application to the US Food and Drug Administration in the first half of 2007.