US FDA panel okays esketamine nasal spray for depressionApril 9, 2019
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the US Food and Drug Administration (FDA) recommended the use of esketamine (Spravato) for treatment resistant depression.
The psychopharmacologic drug advisory committee and drug safety and risk management advisory committee of US FDA jointly voted that data support the favorable benefit-risk profile of esketamine nasal spray CIII for adults living with treatment-resistant depression.
Esketamine is thought to work differently than currently approved therapies for major depressive disorder (MDD). If approved, esketamine would provide the first new mechanism of action in 30 years to treat this debilitating mental illness.
The committees based their support on the safety and efficacy data from five phase 3 studies in patients with treatment-resistant depression: three short-term studies; one maintenance of effect study; and one long-term safety study. In addition, the esketamine research programme provided supportive data from three Phase 2 studies and 19 phase 1 studies in patients with treatment-resistant depression and healthy volunteers.
Esketamine is a glutamate receptor modulator, thought to help restore synaptic connections in brain cells in people with the major depressive disorder.
The US FDA has granted Breakthrough Therapy Designations for esketaine for treatment-resistant depression and for a second indication, major depressive disorder with imminent risk for suicide.