Shots:

• This NDA is on basis of five pivotal studies: three short-term- one withdrawal maintenance of effect and one long-term safety- assessing (esketamine spray + a newly initiated oral antidepressant vs PBO nasal spray + newly initiated antidepressant)
• Results: reduction in depressive symptoms- delayed time to relapse symptoms of depression- better tolerance with no new safety signals
• Janssen aims to file MAA for Esketamine Nasal Spray to EMA for the treatment-resistant depression in H2’18. Esketamine also received from FDA BT designation for treatment-resistant depression

Ref: Johnson & Johnson | Image: Janssen