The FDA is on the brink of approving a breakthrough depression drug.
Johnson & Johnson's esketamine is a fast-acting antidepressant administered by a nasal spray. It is currently being tested for major depressive disorder and suicidal thinking.
If approved, it would be the first major therapeutic advance for depression since Prozac was introduced in 1982. Prozac and other available antidepressants take weeks to kick in.
Esketamine would be for people who have not benefited from at least two different therapies.
FDA staffers did note concern over the increased risk of sedation, dissociation and higher blood pressure observed in the study.
An advisory panel voted in favor of the new drug. The FDA is not mandated to follow the panel’s recommendation and is expected to announce its decision on esketamine by March 4.