Janssen Research & Development, LLC, FDA Advisory Committee Briefing Document: Esketamine Nasal Spray For Patients With Treatment-Resistant Depression

Janssen Research & Development, LLC released this advisory committee briefing document on February 12, 2019 in regards to eskatamine. Eskatamine nasal spray is a novel product developed by Janssen Research & Development for the indication of treatment-resistant depression (TRD).

The briefing document provides three levels of review, including: an executive overview that provides a narrative summarizing the TRD, need for novel treatments, key development program characteristics for esketamine nasal spray, study results, and conclusions; detailed summaries in support of the executive overview; and appendices for additional and more detailed information to complement the sections in the core document.

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