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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


TITUSVILLE, N.J., March 5, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SPRAVATOtm (esketamine) CIII nasal spray for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD).1 People who are currently struggling with major depressive disorder (MDD) are 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.1 It is estimated that approximately one-third of U.S. adults with MDD have TRD.4 SPRAVATOtm carries a Boxed WARNING regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors in pediatric patients and young adults.1 See below for Important Safety Information.

SPRAVATOtm (esketamine) CIII Nasal Spray

Click to Tweet: #BREAKINGNEWS: FDA approves @JanssenUS antidepressant for treatment-resistant depression, marking first new mechanism of action for major depressive disorder in decades. Read full press release here: po.st/rFHeS9 

"It was hard to have any emotions, because I was just numb," said Robin P., an esketamine clinical trial patient. "When I began treatment with esketamine and my symptoms started to lift, I could see very clearly just how depressed I had been. I'm now able to appreciate a wider range of emotions than when I was depressed. My long-term goals have taken shape and actually seem attainable."

Click to Tweet: Robin P., a person living with treatment-resistant #depression, talks about her treatment journey and how she's managing her symptoms. po.st/rFHeS9 

SPRAVATOtm was studied in a robust Phase 3 clinical trial program with more than 1,700 adults with TRD. In a short-term study, those who took SPRAVATOtm and an oral antidepressant experienced superior improvement in depression symptoms at four weeks, compared to those who received a placebo and an oral antidepressant.1 In a long-term study, patients in stable remission taking SPRAVATOtm who continued treatment with the medicine were 51 percent less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.1 

In the clinical trials, the most common side effects of SPRAVATOtm when used along with an antidepressant taken by mouth included: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.1

"Depression is a common and potentially debilitating illness that can have profound emotional, functional and economic impact on both those who suffer and their loved ones. The impact of depression is greatest for those who do not benefit from standard treatments," said Michael E. Thase,* M.D., a professor of psychiatry and director of the Mood and Anxiety Disorders Treatment and Research Program in the Perelman School of Medicine at the University of Pennsylvania, who served as a site principal investigator for the clinical trials. "In Phase 3 clinical trials, we saw this therapy provide sustained improvement to patients with treatment-resistant depression."

SPRAVATOtm uses the first new mechanism of action in decades to treat MDD.1,2,3 SPRAVATOtm works on the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor in the brain. The medicine is administered as a nasal spray that is absorbed by the lining of the nasal passages and into the blood stream.1

"SPRAVATOtm has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "This unique and innovative medicine is a testament to Janssen's heritage of advancing solutions in neuroscience to heal minds and improve health outcomes."  

Once SPRAVATOtm is determined as an appropriate treatment option, in accordance with the REMS, the patient will be treated at a certified treatment center that is trained to administer the medicine and address patient needs. SPRAVATOtm will not be dispensed directly to patients for home use. Instead, SPRAVATOtm will be self-administered by the patient under the direct observation of a healthcare provider. The healthcare provider will then observe the patient for treatment-emergent sedation, dissociation and blood pressure changes for at least two hours, until the patient is safe to leave. Patients should not drive or operate heavy machinery until the next day, following a restful sleep. All patients will be enrolled in the SPRAVATOtm REMS registry to further characterize the risks of serious adverse outcomes from sedation, dissociation, abuse and misuse, and to support safe use of this medicine.1

With the approval of SPRAVATOtm comes a new way of treating TRD. Janssen is working quickly to educate and certify treatment centers in accordance with the REMS so healthcare providers can offer SPRAVATOtm to appropriate patients. Later this month, patients can visit www.SPRAVATO.com for a locator tool and to sign up to receive alerts when new treatment centers are available. More locations will be added over time as new treatment centers become certified.

Janssen CarePath offers a comprehensive support program that helps patients get started on SPRAVATOtm and stay on track. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs, and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.

Please click here for full Prescribing Information.

*Dr. Thase has received research support from Janssen and has served as a paid consultant to the company.

About Treatment-Resistant Depression
Approximately one-third of people who have major depressive disorder (MDD) have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode and are considered to have treatment-resistant depression (TRD).4 TRD is a chronic condition that places an ongoing emotional, functional, and economic burden on the individual, their loved ones, and society.5

Depression may lead to an inability to manage life's demands and maintain social connections, affecting all aspects of one's life, from school and employment, to relationships and overall quality of life.6 Treatment-resistant depression is associated with greater morbidity, higher healthcare costs, and various comorbid conditions.5

About the SPRAVATOtm Clinical Program
SPRAVATOtm was studied in five pivotal Phase 3 trials in more than 1,700 adults with TRD, including but not limited to a short-term study and one long-term maintenance study. SPRAVATOtm was also studied in four Phase 2 studies and 19 Phase 1 studies in patients with TRD and healthy volunteers. Patients who participated in the double-blind Phase 3 studies received SPRAVATOtm or a placebo in addition to a newly initiated oral antidepressant at the start of the treatment phase.1

WHAT IS SPRAVATOtm?1
SPRAVATOtm is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults.

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

It is not known if SPRAVATOtm is safe and effective in children.

The U.S. FDA granted Breakthrough Therapy designation for SPRAVATOtm for treatment-resistant depression. Janssen is also investigating the medicine for a second indication, major depressive disorder with imminent risk for suicide.7 Janssen is currently conducting Phase 3 clinical studies for the second indication. Janssen submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the esketamine treatment-resistant depression indication in October 2018 and anticipates approval later in 2019.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SPRAVATOtm?

SPRAVATOtm can cause serious side effects, including:

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


 ?

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.


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Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATOtm. Your healthcare provider will decide when you are ready to leave the healthcare setting.

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


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Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.


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Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

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SPRAVATOtm Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATOtm is only available through a restricted program called the SPRAVATOtm Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATOtm can only be administered at healthcare settings certified in the SPRAVATOtm REMS Program and to patients enrolled in the program. 

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Increased risk of suicidal thoughts or actions. SPRAVATOtm may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. 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.

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How can I watch for and try to prevent suicidal thoughts and actions?


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Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.


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Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.


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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.

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Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:


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attempts to commit suicide

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worsening depression


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thoughts about suicide or dying

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other unusual changes in behavior or mood






SPRAVATOtm is not for use in children.

Do not take SPRAVATOtm if you:

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

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

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATOtm 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.

How will I take SPRAVATOtm?

What should I avoid while taking SPRAVATOtm?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATOtm. 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 SPRAVATOtm?" 

What are the possible side effects of SPRAVATOtm?
SPRAVATOtm may cause serious side effects including:

The most common side effects of SPRAVATOtm when used along with an antidepressant taken by mouth include: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.

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

These are not all the possible side effects of SPRAVATOtm.

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 SPRAVATOtm and discuss any questions you may have with your healthcare provider.

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. Follow us at www.twitter.com/JanssenGlobal. Janssen Pharmaceuticals, Inc. is one 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 product development and the potential benefits and treatment impact of SPRAVATOtm (esketamine) CIII 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 materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., any of the other Janssen Pharmaceutical Companies of Johnson & Johnson 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 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," in the company's most recently filed Quarterly Report on Form 10-Q and in 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. Neither 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 SPRAVATOtm [Prescribing Information]. Titusville, N.J., Janssen Pharmaceuticals, Inc.
2 Duman RS. F1000Research. 2018;7:F1000. 
3 Dubovsky SL. Psychother and Psychosom. 2018;87:129-139.
4 Rush AJ et al. Am J Psychiatry. 2006;163(11):1905-1917.
5 Mrazek DA et al. Psychiatr Serv. 2014;65(8):977-987.
6 Hofmann S et al. Cogn Behav Ther. 2017; 46(4): 265?286.
7 Johnson & Johnson Press Release. Esketamine Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Major Depressive Disorder with Imminent Risk for Suicide. Available at: https://www.jnj.com/media-center/press-releases/esketamine-recieves-breakthrough-therapy-designation-from-us-food-and-drug-administration-for-major-depressive-disorder-with-imminent-risk-of-suicide. Accessed February 28, 2019. 

 

SPRAVATOtm (esketamine) CIII Nasal Spray Logo

(PRNewsfoto/Janssen)

SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson


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