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

reated with the initial bolus dose of 6.5 mg/kg Aquavan was 91.3% compared to 41.2% for control (p less than 0.001). Of those patients in the 6.5 mg/kg Aquavan arm, 94.6% indicated that they would be willing to be treated again with the same sedative dose, compared to 78.2% of those in the control arm (p less than 0.001). Additionally, 83.3% of patients in the 6.5 mg/kg Aquavan arm reported that they did not recall being awake during the procedure, compared to 55.4% for control (p less than 0.001).

The nature and frequency of sedation-related adverse events were similar between patients who received the Aquavan 6.5 mg/kg dose and those in the control arm, and were predictable for this patient population. Based upon the American Society of Anesthesiologists (ASA) Physical Status Classification System, 52% of patients in this study were classified as P2 (having mild systemic disease such as asthma, obesity or diabetes mellitus), 37% were P3 (having severe systemic disease such as cardiovascular disease that limits activity or severe diabetes with systemic complications), and 6% were P4 (having systemic disease that is a constant threat to life, such as unstable angina pectoris, myocardial infarction, or cerebrovascular accident within the past six months). The most frequently observed sedation-related adverse event in the two study arms was transient hypoxemia (defined as blood oxygen saturation levels less than or equal to 90% for more than 30 seconds at any point, as measured by pulse oximetry), which was observed in 15% of patients who received an initial bolus dose of 6.5 mg/kg of Aquavan compared to 13% of patients who received control. Eight patients (5%) who received 6.5 mg/kg Aquavan experienced hypotension. A single patient with ongoing severe hypoxemia and pneumonia, and a history of COPD, congestive heart failure, anemia and other severe comorbidities received manual ventilation support.

"The collective results of this pivotal program demonstr
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