European Commission authorises Janssen’s anti-depressant Spravato
pharmafile | December 23, 2019 | News story | Sales and Marketing | Janssen, MDD, Nasal Spray, TRD, depression, mental health
The European Commission has approved Janssen’s nasal spray Spravato (esketamine), which is used to treat major depressive disorder (MDD) that has been treatment resistant (TRD).
Bernardo Soares, Medical Director at Janssen UK, said: “We are proud to be introducing this innovative treatment option, which we hope will help to address a significant unmet need.”
The authorisation was based on clinical trial data from a programme treating patients with TRD, including over 1,600 that were treated with Spravato. The five Phase 3 trials included three short-term studies, one randomised withdrawal and maintenance of effect study, and one long-term safety study.
The one-month flexible dosing study in adults under 65 years of age demonstrated statistically significant reductions in depressive symptoms at 28 days for esketamine nasal spray and oral antidepressant compared to oral antidepressant and placebo nasal spray. Approximately 70 percent of esketamine nasal spray-treated patients responded to treatment, with a 50 percent symptom reduction. Also, approximately half of all esketamine nasal spray-treated patients achieved remission at the end of the 4-week study.
Professor Allan Young, Chair of Mood Disorders and Director of the Centre for Affective Disorders at King’s College London, said: “This new treatment represents an exciting new therapeutic option for a common, debilitating and difficult to treat condition. I believe both clinicians and patients will welcome this treatment option for this often-devastating illness.”
Major depressive disorder is a severe and chronic mood disorder. Treatment-resistant depression (TRD) is defined as an inadequate response to two or more currently available treatments with antidepressants in a single, current episode of moderate-to-severe depression. A third of people who suffer from MDD do not respond to treatment and are considered to have TRD.
Conor Kavanagh
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