Janssen has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of esketamine, an investigational nasal spray for major depressive disorder (MDD) in Europe.
If approved, esketamine nasal spray will be licensed in Europe 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.
As a glutamate receptor modulator, esketamine nasal spray is a rapidly-acting antidepressant that is thought to help restore synaptic connections in brain cells in people with TRD – a novel mechanism of action, meaning it works differently to currently available therapies for depression.
If approved, esketamine nasal spray would provide the first new mode of action to treat TRD seen in the last 30 years.
Esketamine nasal spray will be self-administered and patients should be observed under the supervision of a healthcare professional for as long as clinically necessary.
“The results from our Phase 3 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.
The submission is based on five pivotal Phase 3 studies of esketamine nasal spray in patients with TRD: three short-term studies, one randomised withdrawal and maintenance of effect study, and one long-term safety study.
The safety of esketamine nasal spray was evaluated in the five Phase 3 studies (three short-term and two long-term studies) and one Phase 2 study.