MGI PHARMA Announces Positive Results from a Pivotal Phase 3 Study of Aquavan Injection
MINNEAPOLIS -- MGI PHARMA, INC., a biopharmaceutical company focused in oncology and acute care, today announced that a randomized, double-blind, multi-center, pivotal phase 3 trial of Aquavan® (fospropofol disodium) Injection 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, the sedation success rate was 88.7% compared to 27.5% 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.
Data from the phase 3 bronchoscopy trial, together with the results from a phase 3 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). MGI PHARMA plans to submit the Aquavan NDA to the U.S. Food and Drug Administration (FDA) early in the third quarter of 2007. As is consistent with standard medical practice, the three trials comprising the Aquavan pivotal program were conducted without monitored anesthesia care (MAC) sedation, and study drugs were administered by medical personnel as dictated by local investigative site guidelines.
“With more than 40 million procedures per year in the U.S. requiring moderate sedation, Aquavan may address a significant market opportunity,†said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA. “The results of this pivotal program, together with completed pharmacokinetic studies, indicate that Aquavan has a pharmacokinetic and pharmacodynamic profile which may facilitate achievement and maintenance of targeted, controlled sedation by proceduralists. This unique profile may allow patients to recover more quickly following short surgical and diagnostic procedures and could improve facility and physician practice efficiency.â€
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 =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