July 22nd, 2020

// (n)SPRAVATO® (esketamine)* Nasal Spray is Available for Canadian Patients

(n)SPRAVATO® (esketamine)* Nasal Spray is Available for Canadian Patients

A New Antidepressant with a Novel Mechanism of Action to Treat 
Major Depressive Disorder in Adults

TORONTO, July 22, 2020 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that SPRAVATO® (esketamine), following a Notice of Compliance (NOC) from Health Canada, is now available for Canadian patients. SPRAVATO® nasal spray, the first glutamate receptor modulator approved for the treatment of major depressive disorder (MDD), is indicated for use in combination with an oral antidepressant (that is either a SSRI or SNRI**) for the treatment of MDD in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode. 

MDD is a leading cause of disability worldwide1 and can have a profound impact on peoples' lives. In Canada, about 11 per cent of men and 16 per cent of women will experience major depression in the course of their lives.2 Although currently available antidepressants are effective for many patients, the symptoms of depression in up to one-third of patients do not adequately respond to treatment.3 

"Depression is a common and debilitating condition that can have a substantial impact on the emotional and functional well-being of those living with the condition as well as their loved ones. The impact of depression is most significant for those who have gone through multiple treatments without relief," said Dr. Roumen Milev, Vice President, Medical and Academic Affairs, Providence Care Hospital and Director, Centre for Neuroscience Studies, Queen's University, Kingston, Ontario. "In clinical trials, we saw SPRAVATO® provide a sustained improvement in symptoms of major depressive disorder. This new therapy has the potential to change the treatment paradigm for patients and their physicians."

The global SPRAVATO® clinical development program included one Phase 2 (n=108) and five Phase 3 (n=1,601) clinical trials with more than 1,700 patients. Health Canada's approval was based on two pivotal Phase 3 clinical trials; a short-term induction study and a long-term maintenance study.4

In the induction study, those who took SPRAVATO® and an oral antidepressant experienced a statistically significant improvement in depression symptoms at four weeks compared to those who received a placebo and an oral antidepressant.

Patients who participated in the long-term maintenance study who were in stable remission and continued treatment with SPRAVATO®, were 51 per cent less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant. 

"Mood Disorders Society of Canada is pleased that a new treatment option is available for adults with major depressive disorder who have failed multiple previous treatments," said Dave Gallson, National Executive Director, MDSC. "With 227 unique combinations of symptoms for someone with depression, new options that work in novel ways are essential." 

To support safe and responsible use, SPRAVATO® must be administered by the patient under the direct supervision of a healthcare professional and is only available to patients through physicians and pharmacists enrolled in a controlled distribution program called the JANSSEN JOURNEY™ Program.  

About Major Depressive Disorder
MDD is a complex mood disorder caused by various factors, including genetic predisposition, personality, stress and brain chemistry.5 It is characterized by symptoms of a persistently low mood, changes in appetite and sleep, fatigue, loss of motivation, or feelings of worthlessness.6 It can also be associated with a substantial loss in productivity, quality of life and increased mortality from suicide.7

MDD affects more than 264 million people of all ages, globally.8 Although currently available antidepressants are effective for many patients, about one-third of patients do not adequately respond to treatment.9

About the SPRAVATO® Clinical Trial Program
SPRAVATO® nasal spray was evaluated for efficacy and safety in more than 1,700 adult patients (18 to 86 years) who met DSM–5 criteria for MDD and were non–responders to at least two oral antidepressants of adequate dosage and duration, in the current major depressive episode. The development program included five Phase 3 studies (three short-term and two long-term studies) and one Phase 2 dose-ranging study.10

In the Phase 3 program, the most commonly observed adverse reaction in patients treated with SPRAVATO® plus an oral antidepressant were dissociation (involving some degree of detachment from reality), dizziness, nausea, sedation, headache, vertigo, dysgeusia, hypoesthesia, increased blood pressure, anxiety and vomiting.11

About SPRAVATO®
SPRAVATO® nasal spray in combination with an oral antidepressant (that is either a SSRI or SNRI**) is indicated for the treatment of MDD in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode. SPRAVATO® works differently than currently available therapies for MDD. It works on the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor in the brain, which is a different mechanism of action than existing antidepressants. 

SPRAVATO® builds on Janssen's more than 50-plus-year history and commitment to research that makes a difference for people living with mental illnesses, including severe mood disorders.

SPRAVATO® is self-administered as a nasal spray, under the supervision of a healthcare professional and is absorbed through the lining of the nasal passages.12

Please refer to the SPRAVATO® Product Monograph for complete prescribing information.

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/canada. Follow us at www.twitter.com/JanssenCanada. Janssen Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

*All trademark rights used under license. 
** SSRI = Selective Serotonin Reuptake Inhibitor; SNRI = Serotonin-Norepinephrine Reuptake Inhibitor
***Dr. Milev was not compensated for any media work. He has been compensated as a consultant.
**** Dave Gallson was not compensated for any media work. Mood Disorders Society of Canada has received funds for patient engagement.

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®. 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 Janssen Inc., 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 behavior 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.govwww.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 World Health Organization. Depression. Available at: http://www.who.int/mediacentre/factsheets/fs369/en/. Accessed May 5, 2020.
2 Health Canada. It's Your Health. Depress. Available at https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/hl-vs/alt_formats/pacrb-dgapcr/pdf/iyh-vsv/diseases-maladies/depression-eng.pdf. Accessed May 5, 2020.
3 US National Library of Medicine. Pharmacological approaches to the challenge of treatment-resistant depression. Dialogues in clinical neuroscience. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4518696/.Accessed June 19, 2020
4 SPRAVATO® Product Monograph. Janssen Inc. Version date: May 19, 2020.
5 CAMH. Depression. https://www.camh.ca/en/health-info/mental-illness-and-addiction-index/depression. Accessed May 5, 2020.
6 Lam RW, McIntosh D, Wang J, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 1. Disease Burden and Principles of Care. Can J Psychiatry. 2016;61(9):510-523
7 Bakish, D. The Journal of Clinical Psychiatry. New Standard of Depression Treatment: Remission and Full Recovery. J Clin Psychiatry. 2001;62 Suppl 26:5-9
8 World Health Organization. Depression. Available at: http://www.who.int/mediacentre/factsheets/fs369/en/. Accessed May 5, 2020.
9 US National Library of Medicine. Pharmacological approaches to the challenge of treatment-resistant depression. Dialogues in clinical neuroscience. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4518696/.Accessed June 19, 2020
10 SPRAVATO™ Product Monograph. Janssen Inc. Version date: May 19, 2020.
11 SPRAVATO™ Product Monograph. Janssen Inc. Version date: May 19, 2020.
12 SPRAVATO™ Product Monograph. Janssen Inc. Version date: May 19, 2020.

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