Janssen (J&J) Reports Voting Results from FDA Advisory Committees for Spravato (esketamine) in Adults with Resistant Depression

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

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