FDA experts offer a big thumbs up for J&J’s flawed application for ketamine-based depression drug — but trial failures, safety questions spur concerns
J&J may have a deeply flawed application for its new/old drug to treat major depression, but the researchers who turned out to present the case for esketamine encountered a receptive audience of FDA experts on Tuesday.
By a wide margin — 14 yes, 2 no and 1 abstention — the panel concluded that J&J had offered “substantial evidence of the effectiveness of esketamine,” an intranasal version of a powerful anesthetic called ketamine, better known in party circles as ‘Special K.’
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