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SPRAVATO® (esketamine) Demonstrates Superior Efficacy Compared to Quetiapine Extended-Release in Treatment-Resistant Major Depressive Disorder

Data Published in the Current Issue of New England Journal of Medicine.

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TITUSVILLE, N.J., October 04, 2023 – An open-label, international study published today in the New England Journal of Medicine found that patients receiving SPRAVATO® (esketamine) CIII nasal spray for treatment-resistant depression (TRD) were 1.54 times as likely to reach remission after eight weeks than those treated with quetiapine extended-release (XR) at Week 8, (27.1% vs. 17.6%, respectively).1 SPRAVATO®-treated patients were also 1.55 times as likely to stay relapse-free up to 32 weeks after achieving remission at Week 8, without treatment discontinuation, in comparison to those treated with quetiapine XR (21.7% vs. 14.1%, respectively).1

The publication shows for the first time the full breadth of data from ESCAPE-TRD, a randomized, open-label, rater-blinded, active-controlled, ex- U.S. study comparing SPRAVATO® and quetiapine XR, both in conjunction with an oral antidepressant, in adults with TRD.1 SPRAVATO® is indicated along with an oral antidepressant to treat adults with TRD and to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.2

Adverse events and treatment discontinuation rates observed in the study were consistent with the established safety profile of SPRAVATO® and quetiapine XR treatments.1 Treatment-emergent adverse events occurred in 92% of SPRAVATO®-treated patients compared to 78% of quetiapine XR-treated patients. 4.2% of SPRAVATO®-treated patients and 11% quetiapine XR-treated patients discontinued medication due to an adverse event.1

Key study limitations for the ex- U.S. ESCAPE-TRD trial are its open-label study design, differences in treatment compliance and routes of administration between the groups, and differences in patient touchpoints between the two arms. However, the study design better reflects real-world practice by enabling the sites, all located outside of the U.S., to administer treatment according to their respective prescribing labels.

“This large head-to-head trial gives physicians important data to consider in the management of treatment-resistant depression by comparing the short- and long-term effectiveness of SPRAVATO® to an oral antipsychotic,” said Reina Benabou, M.D., Ph.D., Vice President, Medical Affairs, Neuroscience, Janssen Scientific Affairs, LLC. “SPRAVATO® offers patients an additional important option. It is critical that those living with this difficult-to-treat condition have choices to consider for their personal treatment plans, in discussion with their healthcare providers.”

About Treatment-Resistant Depression
Depression is a common mental disorder that impacts an estimated 280 million people worldwide.3 In the U.S., approximately 21 million adults have had at least one major depressive episode, with an estimated one-third—or 2.8 million—of those living with MDD diagnosed with TRD.4,5 TRD places an ongoing emotional, functional and economic burden on the individual, their loved ones and society.4 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.4 People living with MDD are often considered to have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.4

About ESCAPE-TRD1
Escape-TRD is a randomized, open-label, rater-blinded, active-controlled, international, multicenter phase 3b clinical study designed to evaluate the efficacy, safety and tolerability of flexibly dosed esketamine NS compared with quetiapine XR, both in combination with a continuing selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors in subjects with TRD. Select data from ESCAPE-TRD was previously presented at medical congresses in 2022 and 2023.

IMPORTANT SAFETY INFORMATION

What is SPRAVATO® (esketamine) CIII nasal spray?
SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat:

  • Adults with treatment-resistant depression (TRD)
  • Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions

SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.

It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.

It is not known if SPRAVATO® is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SPRAVATO®?

SPRAVATO® can cause serious side effects, including:

  • Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).

o Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
o Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.

  • Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.

o Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
o Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

  • SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
  • Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

SPRAVATO® is not for use in children.

o Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.

  • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

o Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
o Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
o Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

  • Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
o suicide attemptso worsening depression
o thoughts about suicide or dying o other unusual changes in behavior or mood

Do not take SPRAVATO® if you:

  • have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
  • have an abnormal connection between your veins and arteries (arteriovenous malformation)
  • have a history of bleeding in the brain
  • are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.

If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.

Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart or brain problems, including:

o high blood pressure (hypertension)
o slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
o history of heart attack
o history of stroke
o heart valve disease or heart failure
o history of brain injury or any condition where there is increased pressure in the brain

  • have liver problems
  • have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
  • are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.

o Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
o If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
o There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/

  • are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.

Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How will I take SPRAVATO®?

  • You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
  • Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
  • Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
  • During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
  • You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
  • If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
  • Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
  • If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.

What should I avoid while taking SPRAVATO®?

Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”

What are the possible side effects of SPRAVATO®?

SPRAVATO® may cause serious side effects including:

· See “What is the most important information I should know about SPRAVATO®?”
· Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
· Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
· Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.

The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:

· feeling disconnected from yourself, your thoughts, feelings and things around you

· dizziness

· nausea

· feeling sleepy

· spinning sensation

· decreased feeling of sensitivity (numbness)

· feeling anxious

· lack of energy

· increased blood pressure

· vomiting

· feeling drunk

· feeling very happy or excited

If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.

These are not all the possible side effects of SPRAVATO®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider.

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References:
1. Reif A, Bitter I, Buyze J, et al. Esketamine Nasal Spray versus Quetiapine for Treatment Resistant Depression. The New England Journal of Medicine. 2023; N Engl J Med 2023; 389:1298-1309
2. SPRAVATO® [Prescribing Information]. Titusville, N.J., Janssen Pharmaceuticals, Inc.
3. World Health Organization. Depressive Disorder (Depression). World Health Organization website. 2023. Accessed August 2023. Available at: who.int/news-room/fact-sheets/detail/depression.
4. Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. 2021;82(2):20m13699.
5. National Institute of Mental Health. Major Depression. National Institute of Mental Health website. Accessed August 2023. Available at: nimh.nih.gov/health/statistics/major-depression.

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© Janssen Pharmaceuticals, Inc. 2023 09/23

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