With hits and misses in first pivotal trials, J&J confidently maps a path to the FDA with its major depression med esketamine
J&J researchers rolled out data from the first two pivotal trials of their anti-depression drug esketamine today, blazing a trail that they say leads straight to an FDA filing in a matter of months with a groundbreaking approach to treating major depression.
The data are mixed, with some hits and misses, as you’ll see further below as I set out the data points. But there are some important caveats to note about the numbers for a low-dose, intranasal formulation of a powerful anesthetic and frequently abused party drug — better known as Special K — which will invite a very careful examination by regulators.
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