>>Aquavan(R) Phase 3 Bronchoscopy Data Presented At CHEST 2007
Monday October 22, 4:01 pm ET
--Sedation Success Endpoint and Secondary Endpoints of Patient Satisfaction and Safety Presented--
MINNEAPOLIS--(BUSINESS WIRE)--MGI PHARMA, INC. (Nasdaq:MOGN - News), a biopharmaceutical company focused in oncology and acute care, announced today the presentation of results of a successful randomized, double-blind, multi-center, pivotal phase 3 trial of Aquavan® (fospropofol disodium) Injection in patients undergoing flexible bronchoscopy. Primary and secondary efficacy endpoint results, as well as safety data, were presented at CHEST 2007, the annual conference of the American College of Chest Physicians, in Chicago. Aquavan is an investigational drug that is being studied as a sedative-hypnotic agent in patients undergoing brief surgical or diagnostic procedures.
Bronchoscopy Pivotal Trial Results (Abstract # 5639)
A total of 252 patients were randomized and received either a 6.5 mg/kg dose of Aquavan or a control dose of 2.0 mg/kg. 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 as required to initiate or 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 and physician 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<0.001). The treatment success rate among patients treated with the initial bolus dose of 6.5 mg/kg Aquavan was 91.3% compared to 41.2% for control (p<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<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<0.001).
“The results show that Aquavan has a pharmacokinetic profile that may allow pulmonologists to deliver a predictable concentration of sedative and achieve the desired level of sedation for patients undergoing bronchoscopy,” said Gerard A. Silvestri, MD, FCCP, Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, S.C., and a lead investigator of the trial. “These findings corroborate data previously reported from a successful pivotal phase 3 study of Aquavan in patients undergoing colonoscopy.”
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, 43% of patients were classified as P3 (having severe systemic disease), or P4 (having systemic disease that is a constant threat to life). The most frequently observed sedation-related adverse event in the two study arms was transient hypoxemia (defined as blood oxygen saturation levels =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.
MGI PHARMA submitted a New Drug Application (NDA) for Aquavan to the U.S. Food and Drug Administration (FDA) on September 27, 2007. The NDA includes the results of the phase 3 bronchoscopy trial, together with data from a phase 3 study in patients undergoing colonoscopy and an open-label study in patients undergoing minor surgical procedures. A number of additional supportive studies were also included in the application.<<
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Cheers, Tuck |
