J&J seeks FDA approval for Spravato as a solo depression treatment

Johnson & Johnson has submitted an application to the FDA seeking approval for Spravato (esketamine) CIII nasal spray as a standalone treatment for adults suffering from treatment-resistant depression (TRD). This request is underpinned by encouraging data from the phase 4 TRD4005 study, which demonstrated that patients experienced significant improvement in their depressive symptoms within the first 24 hours of administration. Moreover, this positive effect was sustained for a period of at least four weeks. The safety profile of Spravato as a monotherapy was found to be consistent with its safety when used in combination with an oral antidepressant, without any new safety concerns emerging.

Spravato made headlines in 2019 as the first new medication for the treatment of depression to be approved in more than three decades. Initially, it was sanctioned for use in combination with an oral antidepressant specifically for treatment-resistant depression. In the following year, the drug received additional approval for use as an add-on therapy for major depressive disorder (MDD) in patients experiencing acute suicidal ideation and behavior. In December of last year, Johnson & Johnson informed investors of its optimistic sales projections, estimating that annual sales could range between $1 billion and $5 billion.

In recent developments, the pharmaceutical company's experimental drug seltorexant achieved all of its primary and secondary goals in a pivotal phase 3 clinical trial. This study focused on patients with major depressive disorder (MDD) who also exhibited symptoms of insomnia.