Janssen Submits European Marketing Authorisation Application for Esketamine Nasal Spray

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for esketamine nasal spray, a glutamate receptor modulator, for treatment-resistant depression (TRD) in adults with Major Depressive Disorder (MDD) who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

Esketamine nasal spray is an investigational product for the treatment of TRD that is being studied as part of a global development programme. 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 than currently available therapies for depression.

“Major Depressive Disorder affects approximately 40 million people across Europe, and is the leading cause of disability worldwide. Of these people, about one-third do not respond to currently available treatments. Janssen is committed to improving the outcomes for patients with treatment-resistant depression, and we look forward to working with the EMA to provide a new targeted treatment option for these patients,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development.

The MAA 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. Data from these Phase 3 studies demonstrated that treatment with esketamine nasal spray plus a newly initiated oral antidepressant, compared to an active comparator (newly initiated antidepressant plus placebo nasal spray), was associated with rapid reduction of depressive symptoms, as early as day 2, and reduced the risk of relapse by 51% in stable remitters. The long-term safety study showed that the esketamine nasal spray doses studied were generally tolerated, with no new safety signals in dosing up to 52 weeks, comparable to the data from the short-term esketamine nasal spray studies.

The safety of esketamine nasal spray was also evaluated in the five Phase 3 studies (three short-term and two long-term studies) and one Phase 2 study. These data provide insights related to the safety profile of esketamine nasal spray in patients with TRD over the long-term and show that esketamine nasal spray may be beneficial in terms of extending time to relapse in a patient population that is challenging to treat. The most commonly observed adverse reactions with esketamine nasal spray (≥10% of patients) were dissociation, anxiety, dysgeusia, dizziness, sedation, hypoaesthesia, headache, vertigo, nausea, vomiting and increased blood pressure.

“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, M.D., Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. “We look forward to bringing a new treatment option to people who need it most.”

A New Drug Application (NDA) has also been submitted to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray for TRD.

Janssen acknowledges and supports World Mental Health Day, 10th October, a day which drives greater awareness for the 1 in 4 people worldwide affected by a mental health disorder. The heritage and dedication that Janssen has demonstrated in the field of psychiatry spans 60 years this year, and the company is proud to mark this important milestone today in the hope of bringing a new treatment option to patients.