Janssen’s Esketamine Nasal Spray Which Is Similar To the Illegal Opioid Ketamine Gets Approved in the EU
In a latest development, the European Commission (EC) has approved Johnson & Johnson subsidiary Janssen’s Spravato
) nasal spray for treatment-resistant major depressive disorder.
is an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor and is similar in composition to illegal drug ketamine
; Janssen has a risk management plan related to the possibility of associated addiction.
The antidepressant drug
has been approved across the European Union in combination with an oral antidepressant
, either a selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor. It can self-administered by a single-use nasal spray device.
The drug’s approval is based upon the results of five Phase III trials in patients who have not responded to at least two different antidepressant
treatments, and are thus described as treatment-resistant.
Study findings showed that treatment with esketamine
nasal spray plus a new oral antidepressant
regimen was associated with a greater reduction in symptoms of depression than a new antidepressant
plus a placebo nasal spray.
Furthermore, although there was impressive remission at week four, continued treatment with esketamine
reduced the risk of relapse by 70% in patients with stable response and 51% in patients in stable remission.
About 70% of esketamine
-treated patients responded well and experienced at least a 50% reduction in symptom.
Global Head of Neuroscience Therapeutic Area Of Janssen Research and Development, Dr Husseini K. Manji told Thailand Medical
News, “The EC approval of esketamine
nasal spray provides a new way to manage treatment-resistant major depressive disorder
with a novel mechanism of action. Janssen is committed to reducing the devastating burden caused by serious mental illnesses, and we are proud to be introducing a new and innovative treatment option, which will help to address a significant unmet need.”
Professor Allan Young,King’s College London chair of mood disorders
and Centre for Affective Disorders
director commented, “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.”
Professor Siegfried Kasper of International College of Neuropsychopharmacology said, “MDD (major depressive disorder
) is a debilitating illness that can have a profound impact on patients and their loved ones. I have seen patients who have been suffering from MDD for a really long time and have tried multiple different treatments, which often take between four to six weeks to take effect.12 The fast-acting nature of esketamine
nasal spray and the high remission rates seen in the pivotal trials makes it a welcome treatment option for individuals who need it most.”
The European Commission ’s decision comes around nine months after the US Food and Drug Administration’s approval of esketamine
in March 2019..