Drug Development
MGI PHARMA Announces Positive Results from a Pivotal Phase 3 Study of Aquavan Injection in Patients Undergoing Bronchoscopy
Published in Medical Letter on the CDC and FDA, April 8th, 2007
MGI PHARMA, INC. (NASDAQ: MOGN), a biopharmaceutical company focused in oncology and acute care, announced that a randomized, double-blind, multi-center, pivotal phase 3 trial of Aquavan(R) (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...
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