Business Wire

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

Share

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 MDD, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.7

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210208005045/en/

“Depression is more than just feeling sad, it’s a debilitating combination of symptoms that are different for each person and can progress to a point where patients may experience a psychiatric emergency,” said Professor Maurizio Pompili, Director, University Psychiatric Clinic, Sant'Andrea Hospital, Sapienza University of Rome, Italy. “Many antidepressants are effective in treating depressive symptomatology but do not provide rapid relief for patients and can take weeks to achieve their full effect. The fast-acting nature of esketamine nasal spray in these patients may address a key unmet need within this population.”

The EC authorisation of esketamine nasal spray is based on data from the Phase 3 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.4,5 The comprehensive SOC included initial psychiatric hospitalisation and newly initiated or optimised oral antidepressant therapy, 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

Within each study, patients treated with esketamine nasal spray accompanied by comprehensive SOC had a statistically significant and clinically meaningful reduction in depressive symptoms (reduction from baseline Montgomery-Åsberg Depression Rating Scale [MADRS]* total score) at 24 hours after receiving the first dose compared to placebo nasal spray in combination with comprehensive SOC (p=0.006). The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as 4 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).1,8 The most common treatment-emergent adverse events (≥20%) observed in the esketamine nasal spray plus comprehensive SOC group versus the placebo nasal spray plus comprehensive SOC group during the double-blind phase were dizziness (38.3% vs 13.8%), dissociation (33.9% vs 5.8%), nausea (26.9% vs 13.8%), somnolence (20.7% vs 10.2%), and headache (20.3% vs 20.4%), respectively.6

“At Janssen, we are committed to reducing the devastating burden caused by serious mental illnesses and this further authorisation of esketamine nasal spray by the European Commission is a key milestone in our ongoing work towards this goal,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. “Esketamine nasal spray offers adults with MDD who are in need of urgent relief, an effective treatment to reduce their debilitating depressive symptoms. This authorisation provides a new and innovative treatment option to this vulnerable population.”

This EC authorisation is valid in all 27 member states of the European Union as well as the EEA countries (Norway, Iceland and Liechtenstein), and Northern Ireland and Great Britain following the additional step of validation and processing of the baseline submission required following the end of the transition period post-Brexit. Esketamine nasal spray is already authorised by the EC for use in combination with a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor (SNRI), in adult patients with treatment-resistant major depressive disorder (TRD).7

#ENDS#

*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

†Professor Maurizio Pompili has been a paid consultant for Janssen. He has not been compensated for any media work

About SPRAVATO®

As an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, SPRAVATO®▼ (esketamine nasal spray) offers the first new approved mechanism of action in 30 years for an antidepressant.1–3,9

Esketamine nasal spray is self-administered, under the direct supervision of a healthcare professional, through a single-use nasal spray device, offering a novel mode of drug administration 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. 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 2020.10–12

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. 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.13,14 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.15,16 At its worst, MDD can be fatal, with MDD patients demonstrating a 20-fold higher risk of suicide than the rest of the population.17 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.18,19

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/emea. Follow us at www.twitter.com/JanssenEMEA. Janssen Research & Development, LLC and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

# # #

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.

# # #

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. European Medicines Agency. Esketamine nasal spray Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines (last accessed January 2021).
  8. Fedgchin M, et al. Intl J Neuropsychopharmacol 2019;22(10):616–630.
  9. Hillhouse TM & Porter JH. Exp Clin Psychopharmacol 2015;23(1):1–21.
  10. 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 January 2021).
  11. 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 January 2021).
  12. 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 January 2021).
  13. World Health Organisation (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 January 2021).
  14. World Health Organisation (WHO). Depression. Available at: http://www.who.int/news-room/fact-sheets/detail/depression (last accessed January 2021).
  15. World Health Organisation (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 January 2021).
  16. American Psychological Association (APA). Diagnostic and Statistical Manual of Mental Disorders. 5th Ed. 2013.
  17. Lepine JP, et al. Neuropsychiatric Dis Treat 2011;7(suppl 1):3–7.
  18. Machado-Vieira R, et al. Pharmaceuticals 2010;3(1):19–41.
  19. Ionescu D, et al. Dialogues Clin Neurosci 2015;17(2):111–126.

EM-40128
January 2021

Contact information

Media Contact:
Cristiana Maria
Mobile: +32-473-11-28-10
Email: cmaria@its.jnj.com

Investor Relations:
Christopher DelOrefice
Office: +1-732-524-2955

Jennifer McIntyre
Office: +1-732-524-3922

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Scoro Raises $16 Million in Series B Funding To Invest In Its End-to-End Work Management Software9.3.2021 11:00:00 CETPress release

Scoro, an award-winning work management software for professional service businesses, has closed a $16.4 million Series B funding round led by Kennet Partners. Additional investors include Columbia Lake Partners, Inventure, Livonia Partners and Tera Ventures. The investment will fuel continued global expansion and is supported by new French and Spanish versions of the software. “Even before Covid-19 hit, most professional service businesses used as many as a dozen different platforms daily,” said Scoro’s Founder and CEO, Fred Krieger. “However, teams now realise that constantly switching between tools harms productivity and results in lost data and duplicated work. In many ways, these tools became weapons of mass distraction. We’re proud to have the support of Kennet Partners and other investors as we help businesses identify and remove these weapons of mass distraction with our end-to-end work management software.” Scoro's most recent product launch has been a modernization of the Gan

1010data Partners with Strategix CFT to Enhance the Value of Retailer Data and Expand European Coverage9.3.2021 11:00:00 CETPress release

1010data, a provider of analytical intelligence and data sharing solutions to the retail, consumer goods and financial services markets, and Strategix CFT, a boutique consulting company that specializes in innovative retail technologies and comprehensive systems integration, announced today that they have entered into a strategic partnership to provide offerings that deliver enhanced customer insights. Targeted at Retailers and Consumer Packaged Goods (CPG) companies across the UK and Europe, the two companies will use their combined resources to develop analytics solutions that deliver the fastest predictive and prescriptive customer insights. The new partnership will provide advanced data analytics technology driving best practices for large retailers to optimize and grow their business in this fast-changing market environment. This will include a single, powerful source of data enabling collaborative planning between retailers and suppliers. A single, integrated analytics platform e

XPRIZE and Cognizant Announce Grand Prize Winners in Pandemic Response Challenge to Restart Economies Around the World9.3.2021 09:31:00 CETPress release

XPRIZE, the world’s leader in designing and operating incentive competitions to solve humanity’s grand challenges, in partnership with Cognizant(Nasdaq: CTSH), one of the world's leading technology and professional services companies, today announced the Grand Prize Winners in the $500K Pandemic Response Challenge. The four-month global competition was designed to harness the power of data and artificial intelligence in equipping policymakers, health officials and business leaders with the insights and guidance necessary to implement public safety measures that help keep local economies open while minimizing virus outbreaks as vaccines become more widely available. These decision-makers are encouraged to use the results, methodologies and technology from the challenge as reference on approaches to minimize potential outbreaks, now and moving forward. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210309005419/en/ Winning fir

The NAGA Group AG Closes USD 30 Million Financing Framework and Reports Record Growth9.3.2021 09:23:00 CETPress release

The NAGA Group AG (XETRA: N4G, ISIN: DE000A161NR7), provider of the social network for financial market trading NAGA.com, reports on the largest financing arrangement in the company's history to date and further record growth in February 2021. NAGA has signed an agreement with the US Fund Yorkville Advisors securing a growth financing framework of up to USD 30 million. "We are excited about the deal with Yorkville and are setting the course for NAGA to scale even faster. The financing gives us the power and the flexibility to allow the company to be taken to the next level. NAGA is a growth case in a very large and rapidly growing market. This decade will be definitely the breakthrough period for FinTechs", comments NAGA CEO Benjamin Bilski on the closed deal. In addition, the company reports on preliminary results for February which have once again significantly exceeded the record figures from January 2021. In February, NAGA achieved a record user growth with 37,000 new accounts and

Fibocom Announces Multiple Next-Gen 5G NR Modules to 3GPP R16 Standard at MWC Shanghai 20219.3.2021 05:15:00 CETPress release

Fibocom (Stock Code: 300638), a leading provider of cellular embedded wireless module solutions for the Internet of Things (IoT), announced the world-wide launch of the next generation 5G NR modules compliant with the 3GPP R16 standard during Mobile World Congress Shanghai 2021 (MWCS21). The new launch includes FM160 and FG160 5G module series of Sub-6GHz frequency range, as well as FM160W and FG160W series of mmWave range. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210308005973/en/ Fibocom Next-Gen 5G Modules (Photo: Fibocom) Product video on YouTube: https://www.youtube.com/watch?v=Wg0nE1WtoBM The new 5G NR module series is based on the newly-announced Qualcomm® Snapdragon™ X65 and X62 5G Modem-RF Systems and delivers enhanced mobile broadband and high-reliability, low-latency wireless services for IIoT (Industrial IoT), FWA ( Fixed Wireless Access), 4K/8K live streaming, telemedicine, private 5G networks, and other ma

Statement on International Women’s Day 2021 by Julia Simon, Chief Legal and Diversity Officer of Mary Kay Inc.8.3.2021 23:00:00 CETPress release

Below is a statement by Julia Simon, Chief Legal Officer and Chief Diversity Officer, Mary Kay Inc., on International Women’s Day 2021. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210308005888/en/ Julia Simon, Chief Legal Officer and Chief Diversity Officer (Photo: Mary Kay Inc.) Empowered women empower women. This belief serves as the foundation on which all work, internally and externally, rests at Mary Kay Inc. This mantra inspires Mary Kay’s tireless efforts to hire and promote women in leadership positions, support the Women’s Empowerment Principles established by UN Women and UN Global Compact, and develop entrepreneurship and economic opportunities to increase women’s participation and combat gender bias everywhere. If we lift one, we lift all. On International Women’s Day (IWD) 2021 that message rings especially poignant. The theme of this year’s IWD is “Women in leadership: Achieving an equal future in a COVID-19

CGTN: Improving Hong Kong's Electoral System: What's at Stake?8.3.2021 20:06:00 CETPress release

China is mulling improving the electoral system of the Hong Kong Special Administrative Region (HKSAR) – but critics say it's a plan to eliminate opposition forces in the city. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210308005793/en/ Why are improvements imperative? When explaining the draft decision on improving the electoral system of the HKSAR to lawmakers, Wang Chen, vice chairman of the National People's Congress (NPC) Standing Committee, said the move is to prevent anti-China, destabilizing forces from seizing power, citing the months-long riots in 2019. "To remedy the situation, it is important to take necessary steps to improve the electoral system and remove existing institutional deficiencies and risks to ensure the administration of Hong Kong by Hong Kong people with patriots as the main body," Wang said. Alex Fan, founding president of the International Youth Legal Exchange Federation in Hong Kong, told CG

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom