( ation initiation phase (theperiod betw...)Aquavan (Fospropofol Disodium) Injection Data Presented at,Digestive Disease Week 2007,Health

ation initiation phase (the period between the first administered dose and the start of the procedure, i.e., when the scope is inserted), and again at the end of the procedure (i.e., when the scope is removed). The results showed that physician satisfaction ratings were higher for Aquavan 6.5 mg/kg at the end of the procedure (median score 9, versus median score 4 for Aquavan 2.0 mg/kg, pless than0.001). In addition, patients completed a six-question satisfaction survey prior to discharge. Fewer patients who received Aquavan 6.5 mg/kg remembered the scope being inserted (32% versus 45% of patients who received Aquavan 2.0 mg/kg, pless than0.05).

In another sub-analysis, patients were given the Hopkins Verbal Learning Test-Revised (HVLT-R(TM)), an instrument that measures verbal learning and memory retention. Measures of time to fully alert (TTFA) and time to discharge (TTD) were also analyzed, and showed that patients who received Aquavan 6.5 mg/kg achieved a TTFA of 6.7 minutes and a TTD of 8.7 minutes. Among patients who received at least one dose of study drug and no alternative sedative medication, patients in the Aquavan 6.5 mg/kg treatment arm demonstrated a higher mean retention score than those in the midazolam group (70% versus 41%, p less than0.01).

Data from the phase 3 study, together with the results of another phase 3 trial in patients undergoing bronchoscopy and an open-label study in patients undergoing minor surgical procedures, will form the foundation of the Aquavan New Drug Application (NDA).

"There is a need for new agents for moderate sedation that offer an alternative to existing agents. Aquavan was designed to help fulfill this need," said Mary Lynne Hedley, Ph.D., Executive Vice President and Chief Scientific Officer of MGI PHARMA. "We are very pleased with the outcome of this trial and remain on track to submit the Aquavan New Drug Application to the U.S. Food and Drug Administration in the third quarter of this year."<
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