Janssen’s esketamine nasal spray gets Europe approval for new indication

pharmafile | February 9, 2021 | News story | Manufacturing and Production Europe, Janssen 

The European Commission (EC) has authorised the expanded use of Janssen’s Spravato (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of major depressive disorder (MDD), as acute short-term treatment for the rapid reduction of depressive symptoms which, according to clinical judgement, constitute a psychiatric emergency.

The EC’s authorisation of esketamine nasal spray was based on data from the Phase III, short-term, double-blind, randomised, placebo controlled, multicentre, ASPIRE I & II clinical studies conducted globally. These studies compared the efficacy and safety of esketamine nasal spray in combination with comprehensive standard of care (SOC) against placebo nasal spray in combination with comprehensive SOC in adult patients with moderate to severe MDD and current or active suicidal ideation with intent.

The comprehensive SOC included initial psychiatric hospitalisation and newly initiated or optimised oral antidepressant (AD) therapy – AD monotherapy or AD plus augmentation, such as a second antidepressant, an atypical antipsychotic, or a mood stabiliser – which was determined by the treating physician based on clinical judgement and practice guidelines, for the duration of the studies. The comprehensive SOC was enhanced by twice-weekly visits with extensive clinical contact, and concomitant use of benzodiazepines was permitted during the study. Psychotherapy was also permitted during the ASPIRE II trial.

In each study, the primary efficacy measure was the reduction of symptoms of MDD as measured by the change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total score at 24 hours after first dose. Patients treated with esketamine nasal spray accompanied by comprehensive SOC achieved a difference of -3.8 in depressive symptoms at 24 hours after receiving the first dose, compared with placebo nasal spray in combination with comprehensive SOC – a statistically significant and clinically meaningful reduction.

The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as four hours after the first dose. The effectiveness of esketamine nasal spray in preventing suicide or in reducing suicidal ideation or behaviour was not demonstrated. 

Tito Roccia, Therapeutic Area Medical Affairs Director, Neuroscience at Janssen, said: “This authorisation of esketamine nasal spray by the European Commission is a welcome and significant step toward reducing the burden faced by many adults with major depressive disorder in Europe, and is part of Janssen’s commitment to patients with serious mental illnesses.

“This new indication for esketamine nasal spray provides psychiatrists with an innovative treatment option to help their adult patients needing urgent relief from debilitating symptoms during a psychiatric emergency based on clinical judgment.”

Darcy Jimenez

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