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MGI Pharma Announces Positive Results from a Pivotal Phase 3 Study,of Aquavan Injection in Patients Undergoing Bronchoscopy

ents to recover more quickly following short surgical and diagnostic procedures and could improve facility and physician practice efficiency."

Bronchoscopy Pivotal Trial Results

A randomized, double-blind, multi-center phase 3 study was conducted to determine the safety and efficacy of Aquavan for the sedation of patients undergoing flexible bronchoscopies. Patients enrolled in this trial had medical histories that included respiratory disorders (88%), vascular disorders (55%), metabolism and nutrition disorders (55%), and infections (52%). Of all patients enrolled in the trial, 62% were found to have a pulmonary or respiratory abnormality at screening including 52% with chronic obstructive pulmonary disease (COPD) and 20% with a lung mass.

A total of 252 patients were randomized and received either a control dose of 2.0 mg/kg 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 (MOAA/S) scores of less than or equal to 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.

Among patients treated with an initial bolus dose of 6.5 mg/kg (n=150) of Aquavan, the sedation success rate was 88.7% compared to 27.5% of patients in the control arm (n=102) (p less than 0.001). The treatment success rate among patients t
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