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08-Feb-2021

SPRAVATO® ▼ (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Adult Patients with a Moderate to Severe Episode of Major Depressive Disorder

SPRAVATO® ▼ (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Adult Patients with a Moderate to Severe Episode of Major Depressive Disorder

  • This milestone makes esketamine nasal spray the first N-methyl-D-aspartate (NMDA) antagonist to be authorised for adult patients with a moderate to severe episode of major depressive disorder (MDD) in a psychiatric emergency1–3
  • European Commission (EC) authorisation is based on results from two Phase 3 ASPIRE studies, which evaluated the efficacy and safety of esketamine nasal spray used in addition to comprehensive standard of care (SOC)4–6
  • This authorisation marks the second indication for esketamine nasal spray in the European Economic Area (EEA), Northern Ireland and Great Britain7

 

HIGH WYCOMBE, UK, 8 February, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has authorised the expanded use of 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.7

 

The EC authorisation of esketamine nasal spray was based on data from the Phase 3, short-term (four weeks), 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/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 [e.g., second antidepressant, an atypical antipsychotic, or a mood stabilizer]), 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.4,5 Psychotherapy was also permitted during the ASPIRE II trial.5

 

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.7 Patients treated with esketamine nasal spray accompanied by comprehensive SOC achieved a difference of -3.8 (pooled) in depressive symptoms (reduction from baseline MADRS total score) at 24 hours after receiving the first dose compared to placebo nasal spray in combination with comprehensive SOC, which is a statistically significant (p=0.006 in each of the two studies) and clinically meaningful reduction.4,5,7,8 The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as four hours after the first dose.4,5 The effectiveness of esketamine nasal spray in preventing suicide or in reducing suicidal ideation or behaviour was not demonstrated.

 

The safety profile for esketamine nasal spray in this patient population was consistent with previous studies in adults with treatment-resistant major depressive disorder (TRD).1,9 The most common treatment-emergent adverse events (≥20 per cent) observed in the esketamine nasal spray plus comprehensive SOC group versus the placebo nasal spray plus comprehensive SOC group in the ASPIRE 1 trial were dizziness (35.4 per cent vs 8.9 per cent), dissociation (29.2 per cent vs 3.6 per cent), and nausea (20.4 per cent vs 13.4 per cent). In the ASPIRE 2 trial they were dizziness (41.2 per cent vs 18.6 per cent), dissociation (38.6 per cent vs 8.0 per cent), nausea (33.3 per cent vs 14.2 per cent), as well as dysgeusia (25.4 per cent vs 15.9 per cent), somnolence (22.8 per cent vs 10.6 per cent), headache (20.3 per cent vs 20.4 per cent), and paraesthesia (20.2 per cent vs 6.2 per cent) respectively.4,5

 

“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,” said Tito Roccia, Therapeutic Area Medical Affairs Director, Neuroscience, Janssen-Cilag Ltd. “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.”

 

This EC authorisation is valid in all 27 member states of the European Union as well as the EEA countries (Norway, Iceland, and Liechtenstein), Northern Ireland, and may be implemented in relation to the converted EU Marketing Authorisation in Great Britain.

 

Esketamine nasal spray is already authorised by the EC for use in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for adults with treatment-resistant Major Depressive Disorder (TRD), who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.7

 

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*The Montgomery-Åsberg Depression Rating Scale (MADRS): A 10-item diagnostic questionnaire, that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.

 

About SPRAVATO®▼

As an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, SPRAVATO®▼ (esketamine nasal spray) is the first licensed antidepressant (AD) in 30 years that is thought to target the glutamate pathway. 1–3,10

 

Esketamine nasal spray 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. The decision to prescribe esketamine nasal spray should be determined by a psychiatrist.7

 

Esketamine nasal spray was authorised by the European Commission for use in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), in adult patients with treatment-resistant major depressive disorder (TRD) in December 2019.11 The U.S. Food and Drug Administration (FDA) authorised esketamine nasal spray for use in conjunction with an oral antidepressant, for adults living with treatment-resistant major depressive disorder in March 2019 and for use in adults with major depressive disorder with acute suicidal ideation or behaviour in July 2020.12–13

 

Adverse events should be reported. ▼ This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com and to regulatory authorities.

 

For further safety information, please see the Summary of Product Characteristics available at https://www.ema.europa.eu/en/documents/product-information/spravato-epar-product-information_en.pdf.

 

About Major Depressive Disorder

 

Major depressive disorder (MDD) affects nearly 40 million people of all ages in Europe and is one of the leading causes of disability worldwide.14,15 Individuals with depression, including MDD, experience continuous suffering from a serious, biologically-based disease, which has a significant negative impact on all aspects of life, including quality of life and function.16,17 At its worst, MDD can be fatal, with MDD patients demonstrating a 20-fold higher risk of suicide than the rest of the population.18 Despite treatment advances, currently available antidepressant medications can take between four to six weeks to reach their full effect, and one-third of people who suffer from MDD do not respond to these treatments.19,20

 

About the Janssen Pharmaceutical Companies of Johnson & Johnson

 

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

 

Learn more at www.janssen.com/uk. Follow us at www.twitter.com/JanssenUK. Janssen Research & Development, LLC and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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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 regarding SPRAVATO® (esketamine nasal spray). 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 materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including 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 Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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References

  1. Popova V, et al. Am J Psych 2019;176:428–438.
  2. Duman RS, et al. Nat Med 2016;22(3):238–249.
  3. Newport DJ, et al. Am J Psychiatry 2015;172(10):950–966.
  4. Fu DJ, et al. J Clin Psychiatry 2020;81(3):19m13191.
  5. Ionescu D, et al. Int J Neuropsychopharmacol 2020;pyaa068.
  6. Canuso C, et al. Presented at 58th Annual Meeting of Neuropsychopharmacology (ACNP); December 2019.
  7. Summary of Product Characteristics. Spravato 28 mg nasal spray. Janssen-Cilag International. Last updated February 2021.
  8. Duru G, & Fantino B. Current Medical Research and Opinion 2010;24(5):1329–1335
  9. Fedgchin M, et al. Intl J Neuropsychopharmacol 2019;22(10):616–630.
  10. Hillhouse TM & Porter JH. Exp Clin Psychopharmacol 2015;23(1):1–21.
  11. Johnson & Johnson Ltd. Press release on December 2019. Available at: https://www.janssen.com/emea/sites/www_janssen_com_emea/files/spravatorv_esketamine_nasal_spray_approved_in_europe_for_adults_with_treatment-resistant_major_depressive_disorder.pdf (last accessed February 2021).
  12. Johnson & Johnson Ltd. Press release on March 2019. Available at: https://www.jnj.com/janssen-announces-u-s-fda-approval-of-spravatotm-esketamine-ciii-nasal-spray-for-adults-with-treatment-resistant-depression-trd-who-have-cycled-through-multiple-treatments-without-relief (last accessed February 2021).
  13. Johnson & Johnson Ltd. Press release on August 2020. Available at: https://www.jnj.com/janssen-announces-u-s-fda-approval-of-spravato-esketamine-ciii-nasal-spray-to-treat-depressive-symptoms-in-adults-with-major-depressive-disorder-with-acute-suicidal-ideation-or-behavior (last accessed February 2021).
  14. World Health Organization (WHO). Depression and Other Common Mental Health Disorders: Global Health Estimates, 2017. Available at: http://www.who.int/mental_health/management/depression/prevalence_global_health_estimates/en/ (last accessed February 2021).
  15. World Health Organization (WHO). Depression. Available at: http://www.who.int/news-room/fact-sheets/detail/depression (last accessed February 2021).
  16. World Health Organization (WHO). International Classification of Diseases 11th Revision (ICD-11). 6A71.3. 2019. Available at: https://icd.who.int/browse11/l-m/en#/http%3a%2f%2fid.who.int%2ficd%2fentity%2f2139612744 (last accessed February 2021).
  17. American Psychological Association (APA). Diagnostic and Statistical Manual of Mental Disorders. 5th Ed. 2013.
  18. Lepine JP, et al. Neuropsychiatric Dis Treat 2011;7(suppl 1):3–7.
  19. Machado-Vieira R, et al. Pharmaceuticals 2010;3(1):19–41.
  20. Ionescu D, et al. Dialogues Clin Neurosci 2015;17(2):111–126.

EM-51333 February 2021

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Last Updated: 09-Feb-2021