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.
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Restrictive risk management plan for antidepressant nasal spray requires patients be monitored for two hours after dosing and enroll in a patient registry; Janssen has agreed to conduct a monotherapy efficacy trial as a postmarketing commitment.
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