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

ate consistent results for the 6.5 mg/kg initial bolus dose of Aquavan and describe a predictable and effective therapeutic sedation profile in patients with a wide range of heath status and comorbidities who are undergoing a variety of common procedures," said Mary Lynne Hedley, Ph.D., Executive Vice President and Chief Scientific Officer of MGI PHARMA. "We remain on track to submit the Aquavan NDA to the FDA early in the third quarter of this year."

Bronchoscopy Results Consistent with Previously-Reported Colonoscopy Data

The results of this study are consistent with the data previously reported from a pivotal phase 3 study of Aquavan in 312 patients undergoing colonoscopy. The primary endpoint of the colonoscopy trial was also sedation success, and additional endpoints included treatment success and measures of physician and patient satisfaction. In the colonoscopy trial, among patients treated with an initial bolus dose of 6.5 mg/kg of Aquavan, the sedation success rate was 86.7% compared to 25.5% among patients treated with an initial bolus control dose of 2.0 mg/kg of Aquavan (p less than 0.001). Based upon the ASA Physical Status Classification System, 31% of patients in this study were classified as P1 (having no known systemic disease), 65% were classified as P2, 4% were classified as P3, and none were classified as P4. One patient in this study experienced hypoxia after receiving midazolam subsequent to administration of a bolus dose of 6.5 mg/kg Aquavan, which resolved following verbal stimulation.

Minor Surgery Safety Study Results

A single arm, open label study was conducted in 123 patients undergoing a variety of minor surgical procedures to assess the safety and tolerability of Aquavan at a dose of 6.5 mg/kg in a variety of settings including arthroscopy, bunionectomy, dilation and curettage, endoscopy, hysteroscopy, lithroscopy, shunt placement and trans-esophageal echoes. Results of this study also describe a predictable
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