Janssen's nasal spray for depression clears FDA committee
Johnson & Johnson's Janssen Pharmaceuticals, today announced that the Food and Drug Administration’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted (14 yes, 2 no, 1 abstain) that data support the favorable benefit-risk profile of Spravato (esketamine) nasal spray 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, or MDD.
Esketamine is a glutamate receptor modulator, thought to help restore synaptic connections in brain cells in people with major depressive disorder. It is believed to have a novel mechanism of action, meaning it is thought to work differently than currently available therapies for MDD.
"We are pleased with the advisory committees' vote and their recommendation to approve Spravto as a potential therapy for adults living with treatment-resistant depression," Janssen research and development neuroscience therapeutic area global head Husseini Manji said. "Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression."
While the FDA is not bound by the committee's recommendation, it does take its advice into consideration.
The FDA has granted breakthrough therapy designations for esketamine for treatment-resistant depression and for a second indication, major depressive disorder with imminent risk for suicide.
Spravato is an investigational prescription treatment that is thought to work differently than currently approved therapies for major depressive disorder, or MDD.
Esketamine is a glutamate receptor modulator, thought to help restore synaptic connections in brain cells in people with major depressive disorder. It is believed to have a novel mechanism of action, meaning it is thought to work differently than currently available therapies for MDD.
"We are pleased with the advisory committees' vote and their recommendation to approve Spravto as a potential therapy for adults living with treatment-resistant depression," Janssen research and development neuroscience therapeutic area global head Husseini Manji said. "Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression."
While the FDA is not bound by the committee's recommendation, it does take its advice into consideration.
The FDA has granted breakthrough therapy designations for esketamine for treatment-resistant depression and for a second indication, major depressive disorder with imminent risk for suicide.