WOODCLIFF LAKE, N.J., May 7 /PRNewswire/ -- Eisai Corporation of North America and its U.S. subsidiary, MGI PHARMA, INC., today announced that the U.S. Food and Drug Administration (FDA) Advisory Committee on Anesthetic and Life Support Drugs (ALSDAC) has voted 6 to 3 in favor (with one abstention) of approval of fospropofol disodium injection for use as an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures.
The Committee recommended use of fospropofol disodium injection to health care providers who are appropriately trained. Further, the Committee recommended additional studies be conducted in specific patient populations, including those with a variety of comorbidities, for example, in patients who weigh less than 60 kg and the elderly.
"We are encouraged by ALSDAC's support of the efficacy and safety results of fospropofol disodium demonstrated in our clinical studies, and we look forward to continuing our discussions with FDA as they finalize their review of our application," said Mary Lynne Hedley, PhD, Executive Vice President of Eisai Corporation of North America. "We believe the clinical trial data support the use of this product by anesthesiologists and nonanesthesia health care professionals."
FDA reviewers will consider ALSDAC's recommendation in its review of the NDA for fospropofol disodium injection. The FDA is not bound by its Advisory Committees' recommendations.
Data from one Phase II and one Phase III trial in patients undergoing
colonoscopy, a Phase III trial in patients undergoing bronchoscopy, and an
open-label study in patients undergoing a variety of minor surgical
procedures form the foundation of the fospropofol disodium injection NDA.
In total, data from 21 clinical studies involving 1,611 individuals are
included in the application. The clinical trials were conducted by
nonanesthesia health care professionals, and study drugs were administere
|SOURCE Eisai Corporation of North America|
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