MGI Pharma starts Aquavan sedation injection program

By Elaine Rigoli

Tampa, Fla., March 20 - MGI Pharma, Inc. announced the start of the Aquavan (fospropofol disodium) injection pivotal program.

Aquavan is a water-soluble prodrug formulation developed for minimal to moderate sedation of patients undergoing short surgical or diagnostic procedures.

This program consists of two randomized, double-blind, multicenter phase 3 trials and an open-label safety study, according to a company news release.

The first phase 3 trial will enroll 300 patients undergoing colonoscopy. The second phase 3 study will enroll 250 patients undergoing bronchoscopy.

The endpoints of both trials include sedation and treatment success, patient satisfaction, investigator satisfaction and measures of sedation adequacy, recovery, clinical benefit and safety, the release said.

Patient enrollment will be completed by the end of 2006.

The company said it plans to submit a New Drug Application in the first half of 2007.

In addition to the two phase 3 trials, an open label, multi-center safety study will be conducted in 150 patients undergoing minor procedures, including arthroscopy, bunionectomy, dilation and curettage, upper endoscopy, hysteroscopy, lithotripsy, arterio-venous shunt placement and trans-esophageal echocardiograms.

The goal of this study is to assess the safety of a single dose of Aquavan injection in a variety of minor procedures.

MGI Pharma is an oncology- and acute care-focused biopharmaceutical company located in Minneapolis.

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