Janssen has submitted a marketing application to the European Medicines Agency (EMA) seeking approval of investigational nasal spray esketamine for the treatment of major depressive disorder.
The drug has been developed for treatment-resistant depression (TRD) in adults with MDD who have not responded to at least two different treatments with antidepressants in the current moderate-to-severe depressive episode.
Esketamine is a glutamate receptor modulator thought to help restore synaptic connections in brain cells in people with TRD, offering a rapid-acting novel mechanism of action and the first new treatment option for 30 years.
The firm presented data earlier this year showing that continuing treatment with esketamine nasal spray plus an oral antidepressant in patients beyond 16 weeks “showed clinically meaningful and statistically significant superiority” to treatment with an oral antidepressant plus placebo nasal spray in delaying time to relapse of symptoms of depression.
Also, patients in stable remission treated with esketamine nasal spray plus an oral antidepressant reduced the risk of relapse by 51 percent compared to patients receiving an oral antidepressant plus placebo nasal spray.
“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,” said Husseini K. Manji, global head, Neuroscience Therapeutic Area, Janssen Research & Development.
“We look forward to bringing a new treatment option to people who need it most.”