Those voting against approval included Dr. Robert Harrington, professor of medicine, in the division of cardiology, Duke University, Durham, N.C., who cited as concerns the lack of data in the outpatient setting, the small amount of long-term data in those on chronic treatment; and bleeding in cirrhotic patients.
Tolvaptan should be studied in a phase III trial in outpatients, managed by clinicians other than renal and endocrine experts, to “mimic how it will be incorporated into practice,” he said.
The FDA usually follows the recommendations of its advisory panels, which are not binding.
If approved, Otsuka plans to market tolvaptan under the trade name Samska. It would be the second drug approved in this class. In 2005, the FDA approved conivaptan for treating euvolemic hyponatremia in hospitalized patients, but it's administered intravenously.