MGI Pharma (Bloomington, Indiana) said it is on schedule to file for FDA approval of Aquavan (fospropofol disodium) later this year after a pivotal study of the sedative product in patients undergoing bronchoscopy met its primary endpoint, corroborating previously reported findings in colonoscopy patients.

As a result, there's "not a lot of surprise" in the latest data, said Dhesh Govender, an analyst with Monness, Crespi, Hardt & Co. (New York). "The drug works the same way, whether it's in the colon or the bronchial tubes," he told MDD, anesthetizing nerve endings like existing standards of care in this setting.

The principal differences for Aquavan are its quick onset of action, fast recovery period for patients following short surgical and diagnostic procedures, and ease of administration compared to the older products, namely the generic drugs propofol and midazolam, according to a research note from Joel Sendek of Lazard Capital Markets (New York), and those improvements "should provide a competitive advantage" over the currently marketed options.

The most recent Phase III trial produced an 88.7% sedation rate among patients who received an initial bolus dose of 6.5 mg/kg of Aquavan compared to 27.5% of patients who received a control bolus dose of 2 mg/kg of Aquavan (p < 0.001). The study allowed a limited number of supplemental doses of midazolam to be administered to maintain sedation during the procedure.

These bronchoscopy data, together with similar Phase III results in patients undergoing colonoscopy and an open-label study in patients undergoing minor surgical procedures, will serve as the basis of a new drug application to be filed early in the third quarter. More than 40 million of such procedures require moderate sedation every year in the U.S., according to the company.