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news.Oncology focused biopharmaceutical company MGI Pharma has initiated its pivotal program evaluating its Aquavan Injection, a product candidate in development for minimal to moderate sedation of patients undergoing short surgical or diagnostic procedures.
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The pivotal program consists of two randomized, double blind, multicenter phase III trials and an open label safety study. The commencement of the program keeps the company on schedule to submit a new drug application in the first half of 2007.
The first phase III trial is planned to enroll a total of 300 patients undergoing colonoscopy. The second phase III 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 initiation of this pivotal program advances our acute care development pipeline, which will be an important driver of MGI Pharma’s future growth,” said Lonnie Moulder, president and CEO of MGI Pharma. “Aquavan Injection is an excellent companion opportunity to Aloxi Injection for post-operative nausea and vomiting, and together these candidates form the foundation of our acute care franchise.”
In addition to the two phase III 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.