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Janssen's esketamine nasal spray secures CHMP recommendation in Europe for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder

Published on 11/12/20 at 02:20pm

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has moved to recommend Janssen’s Spravato (esketamine nasal spray), when used in combination with standard oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.

Janssen said that the ruling constituted “a psychiatric emergency opinion” in favour of approving the therapy.

The drug application presented Phase 3 data in which Spravato, in combination with comprehensive standard of care, led to a “statistically significant and clinically meaningful reduction in depressive symptoms” 24 hours following initial dosing compared to placebo in moderate to severe MDD patients with current suicidal intent. According the data, benefits of the combo therapy began to emerge as early as four hours after receiving it.

However, Janssen added: “the effectiveness of esketamine nasal spray in preventing suicide or in reducing suicidal ideation or behaviour has not been demonstrated.”

“Immediate intervention for individuals living with MDD who are in a psychiatric emergency is essential,” commented Dr Allitia DiBernardo, European Therapeutic Area Lead for Mood Disorders at Janssen. “Whilst currently available antidepressants are effective in treating depressive symptomatology, they can often take weeks to achieve their full effects, which limits their utility in acute, emergency treatment.”

Around 40 million people are affected by MDD in Europe alone across all age groups, with those affected at 20 times the risk of suicide compared to the general population.

The case for approving the drug in this population will now be reviewed by the European Commission, taking the CHMP opinion into account.

Matt Fellows

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