Johnson & Johnson has filed a request with the FDA to get Spravato (esketamine) CIII nasal spray approved as a standalone treatment for adults with treatment-resistant depression (TRD).
This application is backed by promising results from the phase 4 TRD4005 study. The study found that patients saw rapid improvement in their depressive symptoms within 24 hours of the first dose, and this positive change lasted for at least four weeks. The safety of Spravato as a monotherapy was similar to what’s been seen when it’s used alongside an oral antidepressant, with no new safety reported.
In 2019, Spravato became the first new drug approved to treat depression in more than 30 years when it was approved in conjunction with an oral antidepressant for treatment-resistant depression. A year later, it was approved for use as an add-on to treat major depressive disorder (MDD) with acute suicidal ideation and behavior. In December of last year, J&J informed investors that it expects annual sales to reach between $1 billion and $5 billion.
A few months ago, the drugmaker's investigational therapy, seltorexant, met all primary and secondary endpoints in a pivotal phase 3 study involving patients with MDD and insomnia symptoms.
