TITUSVILLE, N.J. — The Janssen Pharmaceutical Cos. of Johnson & Johnson announced this week that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted that data support the favorable benefit-risk profile of Spravato (esketamine) nasal spray CIII for adults living with treatment-resistant depression.
Spravato is an investigational prescription treatment that is thought to work differently than currently approved therapies for major depressive disorder (MDD).
Janssen announced on September 4, 2018 that it submitted a New Drug Application (NDA) to the FDA for the approval of Spravato. If approved, Spravato would provide the first new mechanism of action in 30 years to treat this debilitating mental illness.
