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Wednesday, October 2, 2019

Janssen files for new indication for Spravato

Janssen (NYSE:JNJ) has submitted a supplemental New Drug Application to the FDA, for a new indication for Spravato (esketamine) nasal spray, for the rapid reduction of depressive symptoms in adult patients with major depressive disorder who have active suicidal ideation with intent.
That is a population that historically has been excluded from antidepressant clinical trials, the company notes.
The sNDA is based on results from the Phase 3 ASPIRE I and II trials, which evaluated efficacy and safety of Spravato vs. placebo in this patient population.
The FDA approved Spravato in conjunction with an oral antidepressant for treating treatment-resistant depression in adults on March 5.
https://seekingalpha.com/news/3503559-janssen-files-new-indication-spravato

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