FDA News

Janssen submits supplemental new drug application for Spravato

Husseini K. Manji, MD
Husseini K. Manji

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental new drug application to the FDA seeking a new indication for Spravato CIII nasal spray for the rapid reduction of depressive symptoms in adults with major depressive disorder who have active suicidal ideation with intent.

According to a company release, the submission follows results from the phase 3 ASPIRE I and II trials. These trials demonstrated the safety and efficacy of Spravato (esketamine) vs. placebo nasal spray in this high-risk patient population when used in addition to comprehensive standard of care, which included newly initiated and/or optimized antidepressant therapy and initial hospitalization.

“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,” Husseini K. Manji, MD, global head of the neuroscience therapeutic area, Janssen Research & Development, said in the release. “It extends our focus on severe manifestations of major depressive disorder beyond the current indication for treatment resistant depression.”

In August 2016, the FDA granted breakthrough therapy designation to esketamine nasal spray for major depressive disorder with imminent risk for suicide. It approved esketamine nasal spray, in conjunction with an oral antidepressant, for treatment-resistant depression in adults in March 2019.

According to data from both ASPIRE trials presented last month at the European College of Neuropsychopharmacology, both met their respective primary efficacy endpoint — a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Åsberg Depression Rating Scale. In both studies, 84 mg of esketamine plus standard of care showed clinically meaningful and statistically significant superiority (P = .006) compared with placebo plus standard of care in rapidly reducing symptoms of major depressive disorder.

For the secondary endpoint of suicidality, the treatment difference between the esketamine and placebo groups was not statistically significant, according to the release.

Disclosures: Manji is an employee of Janssen.

Husseini K. Manji, MD
Husseini K. Manji

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental new drug application to the FDA seeking a new indication for Spravato CIII nasal spray for the rapid reduction of depressive symptoms in adults with major depressive disorder who have active suicidal ideation with intent.

According to a company release, the submission follows results from the phase 3 ASPIRE I and II trials. These trials demonstrated the safety and efficacy of Spravato (esketamine) vs. placebo nasal spray in this high-risk patient population when used in addition to comprehensive standard of care, which included newly initiated and/or optimized antidepressant therapy and initial hospitalization.

“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,” Husseini K. Manji, MD, global head of the neuroscience therapeutic area, Janssen Research & Development, said in the release. “It extends our focus on severe manifestations of major depressive disorder beyond the current indication for treatment resistant depression.”

In August 2016, the FDA granted breakthrough therapy designation to esketamine nasal spray for major depressive disorder with imminent risk for suicide. It approved esketamine nasal spray, in conjunction with an oral antidepressant, for treatment-resistant depression in adults in March 2019.

According to data from both ASPIRE trials presented last month at the European College of Neuropsychopharmacology, both met their respective primary efficacy endpoint — a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Åsberg Depression Rating Scale. In both studies, 84 mg of esketamine plus standard of care showed clinically meaningful and statistically significant superiority (P = .006) compared with placebo plus standard of care in rapidly reducing symptoms of major depressive disorder.

For the secondary endpoint of suicidality, the treatment difference between the esketamine and placebo groups was not statistically significant, according to the release.

Disclosures: Manji is an employee of Janssen.