MGI Pharma submits Aquavan NDA in USA

Minneapolis, USA-based MGI Pharma, which is focused in oncology and acute care, says that it has submitted a New Drug Application for Aquavan (fospropofol disodium) Injection to the Food and Drug Administration for review. Aquavan is an investigational drug that is being studied as a sedative-hypnotic agent in patients undergoing brief surgical or diagnostic procedures.

Data from Phase II and III trials in patients undergoing colonoscopy, a Phase III study in people undergoing bronchoscopy, and an open label study in those undergoing a variety of minor surgical procedures form the foundation of the Aquavan NDA. In total, data from 21 clinical studies, including 1,611 subjects are included in the application. Consistent with standard medical practice, the four foundational trials were conducted without monitored anesthesia care sedation, and study drugs were administered by medical personnel as dictated by local investigative site guidelines, according to MGI.