Johnson & Johnson filed an application with the U.S. Food and Drug Administration for approval of its esketamine nasal spray for adults with major depressive disorder who have active suicidal ideation with intent.
The FDA granted the drug, called Spravato, a breakthrough therapy designation in August for the new indication.
Spravato is already approved as of March as a medication for adults with treatment-resistant depression.
For the new indication, the regulatory agency will review data from two late-stage studies that showed that Spravato decreased depressive symptoms compared to placebo.
However, the drug did not perform statistically better in improving the severity of a patient's suicidal tendency. The New Brunswick, N.J.-based company said in a release that the standard of care already provided substantial benefit, causing the results for Spravato to be less favorable.
"This submission is a significant step in helping a vulnerable patient population by providing a potential treatment option to rapidly reduce symptoms of depression in adults with active suicidal ideation with intent, which constitutes a psychiatric emergency that requires immediate intervention," said Husseini Manji, global therapeutic area head of neuroscience at Johnson & Johnson's Janssen research and development arm.
Analysts expect that Spravato could reach blockbuster status due to its filling a medical need for depression treatments.
