Shots:

• FDA’s PDAC & DSaRM has jointly voted (14 yes- 2 no- 1 abstain) for favorable benefit-risk profile of Spravato (esketamine) nasal spray C-III- based on five P-III studies (including three short term- one maintenance and a long-term study) vs PBO in patients with treatment-resistant depression
• The study demonstrated no new safety signals with well tolerated results- providing support for its NDA filling to the US FDA on 4 Sept-2018- with its expected PDUFA date on 4 Mar-2019
• Spravato (esketamine) is a glutamate receptor modulator nasal spray- used for restoring synaptic connections in the brain cells in major depressive disorders and has received FDA’s BT designation for treatment-resistant depression with imminent risk for suicide

Ref: J&J | Image: Janssen