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Esketamine in patient with treatment resistant depression: Outcome of the temporary authorization for use programme in France

Published online by Cambridge University Press:  13 August 2021

E. Gaudre Wattinne ,
L. Mekaoui ,
M. Rothärmel ,
M.A. Codet  and
S. Bouju
E. Gaudre Wattinne
Affiliation:
Neurosciences, JANSSEN CILAG, ISSY LES MOULINEAUX, France
L. Mekaoui*
Affiliation:
Service Du Pr P. Gorwood, Clinique Des Maladies Mentales Et De L’encéphale (cmme), Centre hospitalier Sainte-Anne, Paris cedex, France
M. Rothärmel
Affiliation:
University Department Of Psychiatry, Centre Hospitalier du Rouvray, Sotteville-lès-Rouen, France
M.A. Codet
Affiliation:
Neurosciences, JANSSEN CILAG, ISSY LES MOULINEAUX, France
S. Bouju
Affiliation:
Neurosciences, JANSSEN CILAG, ISSY LES MOULINEAUX, France
*
*Corresponding author.

Abstract

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Introduction

Esketamine nasal spray has been developed for patients with treatment resistant depression.

Objectives

A cohort Temporary Authorization for Use (ATUc) allowed to collect for a 6-month period the first data in real life

Methods

On 02/08/2019 the French National Agency for Medicines and Health Product Safety granted an early access program for Esketamine nasal spray framed by a specific protocol for patients without therapeutic alternatives. Each treatment request was approved based on inclusion and exclusion criteria. Clinical evolution, treatment management and safety were then spontaneously reported by psychiatrists.

Results

From 09/23/2019 to 03/25/2020, 66 patients were treated. The median age was 53 years and 41 (62.1%) were females. At treatment request, 52 patients (79%), presented a severe current depressive episode based on clinical judgment. The median duration of the disease was 12.2 years and the current episode was 2.6 years. Since the beginning of the current depressive episode, all patients (66) were prescribed ≥2 antidepressants (mean 4.2). Esketamine was initiated in a complete hospitalization setting in 27 patients (55.1%) and in day hospitalization in 22 patients (44.9%).Safety profile was consistent with the one described during clinical study. The most frequently adverse events reported (>10%) were dizziness, sedation, sleepiness, anxiety and dissociation. Most of them appeared after treatment administration and were transient.

Conclusions

ATUc ended on 12/18/2019 after Marketing Authorization granted by European Medicines Agency. Data reported by French psychiatrists are the first collected in this specific population and provide descriptive information on patient characteristics, burden of disease; Esketamine management and practical use at hospital level

Disclosure

Data analysis performed by RCTs and poster conception coordinated by Medergy and funded by Janssen

Keywords

treatment resistant depressionspray nasalglutamatergic pathwayesketamine
Type
Abstract
Information
European Psychiatry , Volume 64 , Special Issue S1: Abstracts of the 29th European Congress of Psychiatry , April 2021 , pp. S692 - S693
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2021. Published by Cambridge University Press on behalf of the European Psychiatric Association
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