Janssen’s Spravato (esketamine) nasal spray has been authorised in Europe for adults with treatment resistant major depressive disorder.
The company has announced that the European Commission (EC) gave the drug the ‘OK’ in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for adults living with treatment-resistant versions of the disorder who have not responded to at least two different treatments with antidepressants.
The commission says it based the authorisation on data from a robust clinical trial programme in patients with treatment resistant depression, including over 1,600 patients treated with esketamine nasal spray.
One of the trials found that approximately 70% of treated patients responded to treatment, with a ≥50 percent symptom reduction. Furthermore, approximately half of all esketamine nasal spray-treated patients achieved remission at the end of the four-week study.
Further, continued treatment reduced the risk of relapse by 70% among patients with stable response and by 51% in patients in stable remission, compared to continuing treatment with an oral antidepressant alone.
The decision also follows the positive opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) on 18 October 2019.
The new treatment represents an “exciting new therapeutic option for a common, debilitating and difficult to treat condition,” said Professor Allan Young, chair of Mood Disorders and director of the Centre for Affective Disorders, King’s College London.
He went on to say “I believe both clinicians and patients will welcome this treatment option for this often-devastating illness.”
Major depressive disorder affects approximately 40 million people across Europe and 1.8 million adults in England alone. People with MDD can suffer with episodes for many months or even years before being diagnosed and the effects go beyond the psychiatric and physical symptoms, and it may also affect employment and education, relationships, health and overall quality of life.