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March 26, 2007
MGI Pharma announced positive results from a phase III trial of Aquavan for the sedation of subjects undergoing surgical or diagnostic procedures. This randomized, double-blind trial enrolled 252 subjects undergoing flexible bronchoscopies. Subjects received either a control dose of 2.0 mg/kg Aquavan or a 6.5 mg/kg dose of Aquavan. The primary endpoint was sedation success, defined as the achievement of three consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of less than or equal to 4 after administration of sedative medication. The secondary endpoint was successful completion of the procedure without the use of alternative sedative medication and without manual or mechanical ventilation. Treatment was generally well tolerated, with adverse events similar between the two groups. Among subjects treated with the dose of 6.5 mg/kg, the sedation success rate was 88.7% compared to 27.5% of those in the control arm (p less than 0.001). The treatment success rate for those in the high dose Aquavan arm was 91.3% compared to 41.2% for those in the control arm (p less than 0.001). Based on positive phase III results, MGI Pharma plans to submit a NDA to the FDA in the third quarter of 2007.
July 10, 2006
Avera Pharmaceuticals announced positive results of a phase II trial of gantacurium chloride, their non-depolarizing ultra-short acting neuromuscular blocker designed to facilitate rapid intubation of patients undergoing surgical procedures. Trial data met their primary efficacy endpoint, with >90% of treated subjects achieving "acceptable" intubation within 60 seconds of drug injection. The drug was generally well tolerated and no serious adverse events were reported. This multi-center, randomized, controlled, observer-blinded dose-response study enrolled 230 subjects, who received the drug or placebo prior to intubation.
April 4, 2005
Guilford Pharmaceuticals issued results of a phase III trial of their investigational sedative Aquavan (GPI-15715). Primary efficacy data met their endpoints, with 96% of subjects receiving Aquavan achieving satisfactory sedation, as measured in the study by patient performance on the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) diagnostic scale, and by the absence of need for additional sedative medication or ventilation assistance. Sedation response generally occurred within 2 minutes, with recovery from the procedure within 11 minutes. The sedation produced by Aquavan was generally observed to be deeper and longer than with midazolam, which may have contributed to the significantly higher incidence of adverse events with the drug, compared to midazolam. This randomized, open-label study enrolled 278 patients, who received treatment with Aquavan (n=209) or placebo (n=69) during elective colonoscopy. Guilford announced that, due to the high incidence of adverse events, it was suspending enrollment in all of its ongoing trials of Aquavan, pending investigation of lower-dose treatment regimens.
March 21, 2005
Manhattan Pharmaceuticals announced safety data from a phase I pilot study of their investigational sedative propofol lingual spray. These data were also to be presented at the 79th Clinical and Scientific Congress of the International Anesthesia Research Society in Honolulu, Hawaii. Preliminary safety, tolerability and pharmacokinetic data indicated that 72.7% subjects achieved measurable serum drug concentrations without incidence of adverse events, with detectable drug levels 4 minutes after dosing and a mean time to maximum blood concentration was approximately 30 minutes. This single-center, randomized, double-blind, placebo-controlled dose-escalating study enrolled 11 healthy subjects, and investigated the safety, pharmacokinetics and bioavailability of three escalating doses of the drug.
November 24, 2003
Guilford Pharmaceuticals reported positive preliminary results from a phase II trial investigating Aquavan, an injectable prodrug of propofol being developed as a sedative/hypnotic. Results showed that Aquavan provided rapid onset and rapid recovery from sedation/anesthesia without serious adverse effects. Data showed that the median time to full alertness after removal of the colonoscope was 12 minutes, and the median time to full recovery was 20 minutes. The open label, multi-center, adaptive dose ranging study enrolled 77 subjects and was designed to test Aquavan Injection in combination with fentanyl citrate in subjects undergoing colonoscopy. Measurements of sedation were determined using the Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale.