Guilford Announces Phase III Aquavan Trial Meets Primary Endpoint
Guilford Pharmaceuticals has announced that a Phase III study of Aquavan injection in patients undergoing elective colonoscopy procedures met its primary efficacy endpoint without any serious adverse events.
The results were based on a randomized, open-label study designed to assess the efficacy of Aquavan and its safety versus midazolam HCl for sedation in patients undergoing colonoscopy procedures. A total of 278 patients were enrolled and randomly assigned to receive Aquavan or midazolam.
The primary efficacy endpoint in the trial was success of sedation, defined as three consecutive Modified Observer's Assessment of Alertness/Sedation scores less than or equal to four, and completing the procedure without employing alternative sedative medications and without requiring manual or mechanical ventilation.
Treatment with Aquavan resulted in a sedation success rate of 96 percent. In general, patients who received Aquavan experienced deeper levels of sedation for longer sustained periods than patients who received midazolam, which led to a higher level of adverse events in the Aquavan treatment group. Patients treated with Aquavan showed a median time to sedation of two minutes and a median time to full recovery from the end of the procedure of 11 minutes.