MOGN with very good news on PIII trial
MGI PHARMA Announces Positive Results from a Pivotal Phase 3 Study of Aquavan(R) Injection in Patients Undergoing Bronchoscopy
Tuesday March 20, 7:01 am ET
Primary and Secondary Endpoints Achieved
Open Label Safety Study in Minor Surgeries Successfully Completed
NDA Submission Remains on Track for 3Q07
MINNEAPOLIS--(BUSINESS WIRE)--MGI PHARMA, INC. (NASDAQ: MOGN - News), a biopharmaceutical company focused in oncology and acute care, today announced that a randomized, double-blind, multi-center, pivotal phase 3 trial of Aquavan® (fospropofol disodium) Injection for sedation of patients undergoing bronchoscopy successfully met its primary endpoint of sedation success as well as all secondary endpoints. Among patients who received an initial bolus dose of 6.5 mg/kg of Aquavan, the sedation success rate was 88.7% compared to 27.5% of patients in the control arm (p less than 0.001). Results of this trial also indicate that the safety profile of the 6.5 mg/kg dose of Aquavan was predictable and similar to the safety profile of the control.
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