J&J seeks approval for Spravato as monotherapy in resistant depression

Johnson & Johnson announced on Monday that it has submitted an application to the FDA to expand the use of its Spravato (esketamine) nasal spray to include monotherapy for adult patients with treatment-resistant depression (TRD). Currently, Spravato is approved in the United States and Europe for use in conjunction with an oral antidepressant to treat TRD, and it is also approved by the FDA to address depressive symptoms in adults experiencing acute suicidal thoughts or behavior. If the new application is approved, Spravato would become the first standalone treatment for a particularly challenging group of depression patients.

The application is backed by encouraging data from the Phase IV TRD4005 study, which demonstrated a swift reduction in depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Improvements were noted as quickly as 24 hours after the initial dose and persisted for at least four weeks. Johnson & Johnson stated that the safety profile of Spravato as a monotherapy is consistent with the data available for its use alongside an oral antidepressant, with no new safety issues identified.

Bill Martin, Johnson & Johnson's global therapeutic area head for neuroscience, emphasized the potential impact of the new application. He noted that many patients with difficult-to-treat depression endure prolonged periods cycling through various treatments that fail to alleviate their symptoms effectively. Martin expressed the company's eagerness to collaborate with the FDA to introduce this innovative treatment as a standalone option for patients.

Spravato has seen significant commercial success, generating $689 million in sales in 2023, an 84% increase from the prior year. If approved as a monotherapy, Spravato could provide a new treatment option for the estimated 30% of the 280 million people globally who suffer from major depressive disorder and have TRD. This condition is characterized by an inadequate response to at least two different oral antidepressants during the same depressive episode.

The potential for Spravato to be used as a monotherapy is further supported by the positive results from the Phase III ESCAPE-TRD trial, reported in November. This study compared Spravato to quetiapine XR, both administered in combination with continuing antidepressant therapy, in adults with TRD. Spravato proved to be more effective, with over 27% of participants achieving remission after eight weeks compared to about 18% in the quetiapine XR group.

In summary, Johnson & Johnson's recent FDA application aims to expand the label of Spravato to include its use as a monotherapy for adult patients with treatment-resistant depression. Supported by positive clinical trial results, this move could make Spravato the first standalone therapy for a subset of depression patients who struggle to find effective treatment with existing options. If approved, it could offer a new hope for millions globally who continue to suffer from major depressive disorder despite trying multiple treatments.