J&J's Mixed Phase III Data For Esketamine Highlight Challenges In Resistant Depression
J&J released data from the first two Phase III trials testing esketamine in patients with treatment-resistant depression, but only one study met the primary efficacy endpoint.
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Datamonitor projects the newly US FDA-approved esketamine product for treatment-resistant depression will reach sales of almost $2bn in the US, Japan and five major European markets.
Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.
Janssen’s Esketamine: US FDA Panel To Weigh Efficacy, REMS Restrictions For Treatment-Resistant Depression
FDA proposes requiring that healthcare facilities monitor patients for sedation and dissociative effects for two hours after self-administration; reliance on a randomized withdrawal trial as one of two adequate, well-controlled studies to support approval would be a first in the depression setting.