Janssen seeks approval from EMA for investigational nasal spray

European Medicines Agency has been asked to approve Janssen’s investigational nasal spray esketamine, a glutamate receptor modulator, for adults with major depressive disorder who have not responded to at least two different antidepressant treatments in the current moderate-to-severe depressive episode. It is hoped that the product will help restore synaptic connections in brain cells in patients with treatment-resistant depression.
In terms of time to relapse of depressive symptoms, Phase III study data demonstrated that Janssen’s product and an oral antidepressant showed significant superiority in patients treated past 16 weeks versus treatment with an oral antidepressant plus placebo nasal spray. Additionally, there was a 51% reduction in the risk of relapse for patients in stable remission treated with esketamine nasal spray plus an oral antidepressant, versus patients receiving an oral antidepressant plus placebo nasal spray.
Global head, Neuroscience Therapeutic Area, Janssen Research & Development, Husseini K. Manji, said: “The results from our Phase III studies reinforce the potential of esketamine nasal spray as a novel treatment to help patients who haven’t responded to available therapies. We look forward to bringing a new treatment option to people who need it most.”