MGI PHARMA REPORTS DATA ON PROPOFOL PRODRUG

MGI Pharma announced that a randomized, double-blind, multicenter, pivotal Phase III trial of Aquavan 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 (fospropofol disodium), the sedation success rate was 88.7 percent, compared with 27.5 percent of patients in the control arm. 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, the company said.

The randomized, double-blind, multicenter study was conducted to determine the safety and efficacy of Aquavan for the sedation of patients undergoing flexible bronchoscopies. A total of 252 patients were randomized and received either a control dose of 2.0 mg/kg of Aquavan or a 6.5 mg/kg dose of Aquavan. Following administration of the initial bolus dose of the study drug, the design of this trial allowed a limited number of supplemental doses to be administered to maintain sedation during the procedure.

The primary endpoint of this trial was sedation success, defined as a patient having achieved three consecutive Modified Observer's Assessment of Alertness/Sedation scores of 4 after administration of sedative medication and completion of the bronchoscopy procedure without the use of alternative sedative medication and without manual or mechanical ventilation. The secondary endpoint of treatment success was defined as completion of the procedure without the use of alternative sedative medication and without manual or mechanical ventilation. Additional endpoints included measures of patient satisfaction.

Data from the Phase III bronchoscopy trial, together with the results from a Phase III trial in patients undergoing colonoscopy and an open-label study in patients undergoing minor surgical procedures, will form the foundation of the Aquavan new drug application (NDA). The company plans to submit the NDA to the FDA early in the third quarter of 2007.

Aquavan is a water-soluble prodrug of propofol, meaning that that after intravenous injection it is rapidly converted into propofol.