Johnson & Johnson presents findings from the largest European real-world dataset for esketamine nasal spray (NS) which confirm its effectiveness and tolerability in a real-world patient population, which on average had severe, chronic, treatment-resistant depression (TRD).
The study offers distinct new insight into the durability of treatment effect, with symptom stability maintained across 6 months following discontinuation of esketamine NS.
BEERSE, BELGIUM, March 28, 2026 (GLOBE NEWSWIRE) — Johnson & Johnson today announced new data from the ECHO study which support the effectiveness and safety profile of SPRAVATO® (esketamine NS) and indicate durability of treatment effect across 6 months after treatment discontinuation in a real-world setting for patients with TRD. These data are being presented at this year’s European Psychiatric Association (EPA) Congress, taking place March 28-31, in Prague, Czech Republic.
Key study findings reinforce robust effectiveness of esketamine NS
From across Europe and Israel, 570 patients started the variable treatment period (TP) (mean duration of 9 months) and 301 participants continued into the 6-month post-treatment follow-up (PTFP).1
Treatment with esketamine NS resulted in significant and meaningful improvements in depressive symptoms, with a mean MADRSa change from TP baseline to week 4 of –10.3 points (95% CI: −11.1, −9.5; p<0.001), to week 12 of –14.4 points (95% CI: −15.4, −13.5; p<0.001), and to week 48 of −17.6 points (95% CI: −19.4, −15.8; p<0.001).1
“These results reinforce esketamine nasal spray as an effective option for adults with treatment resistant depression, many of whom have spent too long cycling through treatments that don’t meaningfully improve their symptoms”, said Christine Reif-Leonhard, MD, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt – Goethe University Frankfurt, Frankfurt am Main, Germany.b “The essential real-world insights gained from the ECHO study complement existing randomised clinical trial findings, further guiding clinical practice and allowing us to optimise personalised treatment pathways for our patients with treatment resistant depression.”
The safety profile was consistent with the established profile of esketamine NS2, with no new safety signals identified.c
The first real-world data to show effect durability after patients stopped treatment
MADRS scores remained stable after stopping esketamine NS with a mean change of –1.4 points from PTFP baseline to week 24.1 This indicates the durability of effect, as most patients maintained symptom stability with no sign of relapse.
“The ECHO study is unique in that, for the first time, we have evaluated the durability of effect in real world practice after stopping esketamine nasal spray treatment in patients with treatment resistant depression. We were thrilled to see sustained symptom stability across the 6-month follow-up period”, said Tamara Werner-Kiechle, MD, Therapeutic Area Head, Neuroscience, Cardiopulmonary and Early Portfolio, Europe, Middle East & Africa, Johnson & Johnson. “Creating respite from severe depressive symptoms that lasts beyond the immediate treatment period will significantly improve the lives of people affected, both directly and indirectly, by this devastating disease.”
Understanding the important real-world context
Real-world treatment with esketamine NS presented variability in treatment exposure, reflecting individualised clinical decision-making and patient preferences.
The mean treatment duration in the ECHO study was around 9 months with esketamine NS 84 mg being the highest dose taken in 79.3% of patients and the most frequently administered dose in 67.4% of patients.1
The real-world patient cohort was clinically complex with high severity and chronic TRD (>3-year episodes, mean MADRS 33.3), treatment resistance (mean of 3.8 prior treatment failures in the current episode), and 45.6% of patients had substantial psychiatric comorbidities.1
Around 47% of ECHO study participants were not working, underlining the severity of illness observed and the real-world implications this can have.1
Editor’s Notes:
- The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale used to measure the severity of depressive symptoms in patients with mood disorders.3
- Dr. Christine Reif-Leonhard has provided consulting and advisory services to Johnson & Johnson. She has been remunerated for the media work.
- Treatment-emergent adverse events (TEAEs) were observed in 81.4% of patients, and 7.7% experienced an adverse event which led to treatment discontinuation. 34.9% of patients reported TEAEs with a maximum severity of mild. The most commonly reported TEAEs were dissociation (35.1%), dizziness (33.5%) and increased blood pressure (21.4%).1
ABOUT THE ECHO RWE STUDY
Esketamine CoHOrt (ECHO) is a prospective, international, non-interventional Phase 4 study designed to observe esketamine NS effectiveness and safety in real-world clinical settings.1 It is the first study to evaluate durability of effect after treatment discontinuation with esketamine NS.1 From across Europe and Israel, 570 participants with treatment resistant depression (TRD) were enrolled into the treatment period, of which 301 participated in the post-treatment follow-up period.1 Mean and median treatment period durations were 267 days (~9 months) and 190 days (~6 months) respectively, the post-treatment follow-up period was 24 weeks (~6 months).1 Esketamine NS 84mg was the highest dose taken in 79.3% of patients and the most frequently administered dose in 67.4%.1
ABOUT MAJOR DEPRESSIVE DISORDER (MDD)
Depressive disorders affect over 21 million people across EU countries.4 The incidence of depression is rising in Europe and is expected to become the leading cause of disease burden globally by 2030.4,5 MDD is characterised by persistent sadness, loss of interest or pleasure in daily activities (anhedonia), and changes in sleep and appetite.6
Approximately one-third of people living with MDD have been reported to develop treatment resistant depression (TRD), meaning their depression has not responded to at least two consecutive, adequately dosed, antidepressants during the same depressive episode.7
TRD has a significant negative impact, emotionally and functionally, on the individual and their loved ones.8,9 The burden of TRD is disproportionately higher among people who do not respond to antidepressant treatments and is likely underestimated because there is limited published research on the use of social services and the burden for caregivers.8
ABOUT SPRAVATO® (esketamine nasal spray)
As an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, esketamine NS has a different mechanism of action and drug administration compared to other approved depression treatments.10,11 Esketamine NS is self-administered, under the direct supervision of a healthcare professional, through a single-use nasal spray device, for the treatment of patients within the licensed indications.10 The decision to prescribe esketamine NS should be determined by a psychiatrist.10
Esketamine NS was authorised by the European Commission in December 2019 for use in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin–norepinephrine reuptake inhibitor (SNRI) in adult patients with TRD who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.10 It is also approved for co-administered use with 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.10
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using esketamine nasal spray please refer to the Summary of Product Characteristics.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Learn more at https://www.jnj.com/innovativemedicine/emea/
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CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to SPRAVATO®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behaviour and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.
Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Source: Johnson & Johnson
For European medical and trade media only. Not for distribution in the UK, Ireland and BeNeLux.
CP-572382
March 2026
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REFERENCES
1 Rosso G, et al. ECHO: Results from a Non-Interventional Cohort Study of Esketamine Nasal Spray in Treatment Resistant Depression. Poster presentation (EPP405) at European Psychiatric Association Congress 2026. March 2026.
2 McIntyre RS et al. Safety and tolerability of esketamine nasal spray versus quetiapine extended release in patients with treatment resistant depression. European Neuropsychopharmacol. 2024; 85:58-65.
3 Leucht, S et al. What does the MADRS mean? Equipercentile linking with the CGI using a company database of mirtazapine studies. Journal of affective disorders vol. 210 (2017): 287-293. doi:10.1016/j.jad.2016.12.041
4 OECD/EU. Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. Available at https://health.ec.europa.eu/document/download/e7612c76-68c5-43ba-808e-88416c40a702_en?filename=2018_healthatglance_rep_en.pdf. Last accessed March 2026.
5 World Health Organization. 2011. Global burden of mental disorders and the need for a comprehensive, coordinated response from health and social sectors at the country level. Available from: https://apps.who.int/gb/ebwha/pdf_files/EB130/B130_9-en.pdf. Last accessed: March 2026.
6 Mayo Clinic. 2022. Depression (major depressive disorder) – Symptoms and causes. Available from: https://www.mayoclinic.org/diseases-conditions/depression/symptoms-causes/syc-20356007. Last accessed: March 2026
7 McIntyre RS, et al. Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions. World Psychiatry. 2023; 22(3):394-412.
8 Mrazek DA et al. A Review of the Clinical, Economic, and Societal Burden of Treatment-Resistant Depression: 1996- 2013. Psychiatr Serv. 2014; 65(8):977-987.
9 World Health Organization. 2025. Depressive Disorder (depression). Available from: https://www.who.int/news-room/fact-sheets/detail/depression. Last accessed: March 2026.
10 European Medicines Agency (EMA). Summary of Product Characteristics: SPRAVATO. Available from: https://www.ema.europa.eu/en/documents/product-information/spravato-epar-product-information_en.pdf. Last accessed: March 2026
11 Hillhouse T, et al. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015; 21:1–21.
