Johnson & Johnson files sNDA for SPRAVATO depression treatment

Johnson & Johnson has submitted a supplemental new drug application (sNDA) seeking approval from the US Food and Drug Administration (FDA) for its SPRAVATO (esketamine) CIII nasal spray as a monotherapy for adults with treatment-resistant depression (TRD). This move aims to expand the use of SPRAVATO beyond its current approval as an adjunctive therapy used with oral antidepressants.

The sNDA submission is primarily grounded on the positive results from the Phase IV TRD4005 study. This study was a randomized, multicenter, double-blind, placebo-controlled trial that assessed the efficacy, safety, and tolerability of SPRAVATO when used as a standalone treatment. The trial outcomes showed a notable improvement in the Montgomery-Asberg Depression Rating Scale total score within just 24 hours after the initial dose, maintaining these positive effects for at least four weeks.

SPRAVATO’s safety profile as a monotherapy was consistent with the existing clinical data for oral antidepressants, and no new safety issues were identified during the study. Currently, SPRAVATO is FDA-approved to be used in combination with an oral antidepressant for adults with TRD, as well as for addressing depressive symptoms in adults with major depressive disorder (MDD) who experience acute suicidal ideation or behavior.

Globally, the treatment has received regulatory approval in 77 countries and has been used by over 100,000 individuals. Among the estimated 280 million people worldwide diagnosed with MDD, about 30% are affected by TRD, which is defined by an inadequate response to at least two different oral antidepressants during the same depressive episode.

Bill Martin, the Global Therapeutic Area Head for Neuroscience at Johnson & Johnson, highlighted the significant burden that TRD imposes on patients and their families. He noted that many individuals with challenging-to-treat depression endure prolonged periods of ineffective treatments, which exacerbates their functional and emotional distress. Martin expressed satisfaction with the decade-long research supporting the safety and efficacy of SPRAVATO and indicated the company's eagerness to collaborate with the FDA to make this innovative monotherapy available to patients.

In addition to the progress in its pharmaceutical advancements, Johnson & Johnson recently reported a 12.8% decrease in net earnings for the second quarter of 2024. The earnings fell from $5.3 billion in the same period the previous year to $4.6 billion.