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J&J Looks To Expand Spravato Label To Suicidal Ideation

 
• By Leah Samuel

The big pharma will seek the new indication later this year based on Phase III data showing a rapid decrease in depression symptoms, but without a significant improvement over placebo in suicidality.

Depression-blocks

Johnson & Johnson will file a supplemental new drug application (sNDA) for Spravato (esketamine) by the end of the year for the treatment of adults with major depressive disorder who have suicidal intent. Two Phase III clinical trials in the challenging patient population met the primary endpoint of reducing depressive symptoms but missed what could have been an important secondary endpoint, improvement in severity of suicidality.

The company announced results from the two Phase III trials testing esketamine in patients with suicidal ideation on 9 September....

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