About Esketamine
Esketamine nasal spray is an investigational compound being studied by Janssen Research & Development, LLC as part of a global development program. Esketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, which has a novel mechanism of action, meaning it works differently than currently available therapies for depression.

Esketamine nasal spray received Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA) in November 2013 for treatment-resistant depression and in August 2016 for the indication of major depressive disorder with imminent risk for suicide.¹

About Major Depressive Disorder
Major depressive disorder affects nearly 300 million people of all ages globally and is the leading cause of disability worldwide.² Individuals with depression, including major depressive disorder, 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.³ Although currently available antidepressants are effective for some patients, about one third of patients do not respond to treatment and are thought to have treatment-resistant depression.⁴

About Schizophrenia
Schizophrenia is a complex and chronic brain disorder that can be severe and disabling. It affects approximately 2.4 million U.S. adults,⁵ often beginning in the late teens or early twenties. The disease typically manifests as hallucinations, delusions and disorganized thoughts and behavior.

 INDICATION

INVEGA TRINZA^® (3-month paliperidone palmitate) is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA^® is used in people who have been treated with INVEGA SUSTENNA^® (1-month paliperidone palmitate) for at least 4 months.

INVEGA SUSTENNA^® (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA^® is used to treat schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about INVEGA TRINZA^® and INVEGA SUSTENNA^®?

INVEGA TRINZA^® and INVEGA SUSTENNA^® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis).  INVEGA TRINZA^® and INVEGA SUSTENNA^® are not for treating dementia-related psychosis.

Do not receive INVEGA TRINZA^® or INVEGA SUSTENNA^® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA TRINZA^® or INVEGA SUSTENNA^®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA TRINZA^® and INVEGA SUSTENNA^®ingredients.

Before you receive INVEGA TRINZA^® or INVEGA SUSTENNA^®, tell your healthcare provider about all your medical conditions, including if you: 

• have had Neuroleptic Malignant Syndrome (NMS)
• have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
• have or have had low levels of potassium or magnesium in your blood
• have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
• have or have had kidney or liver problems
• have diabetes or have a family history of diabetes
• have had a low white blood cell count
• have had problems with dizziness or fainting or are being treated for high blood pressure
• have or have had seizures or epilepsy
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if INVEGA TRINZA^® or INVEGA SUSTENNA^® will harm your unborn baby
• If you become pregnant while taking INVEGA TRINZA^®, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry
• Infants born to women who are treated with INVEGA TRINZA^® or INVEGA SUSTENNA^® may have withdrawal symptoms or other symptoms such as tremors, muscle spasms, abnormal movement of arms and legs, and twitching of eyes.
• are breastfeeding or plan to breastfeed. INVEGA TRINZA^® and INVEGA SUSTENNA^® can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will receive INVEGA TRINZA^® or INVEGA SUSTENNA^® or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine.

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare provider for the potential risk of falls.

 What should I avoid while receiving INVEGA TRINZA^® or INVEGA SUSTENNA^®?

• INVEGA TRINZA^® and INVEGA SUSTENNA^® may affect your ability to make decisions, think clearly, or react quickly.Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA TRINZA^® or INVEGA SUSTENNA^® affects you

• avoid getting overheated or dehydrated

INVEGA TRINZA^® and INVEGA SUSTENNA^® may cause serious side effects, including:

• See "What is the most important information I should know about INVEGA TRINZA^® or INVEGA SUSTENNA^®?"

• stroke in elderly people (cerebrovascular problems) that can lead to death

• Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA TRINZA^® or INVEGA SUSTENNA^®. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure

• problems with your heartbeat. These heart problems can cause death. Call your healthcare provider right away if you have any of these symptoms: passing out or feeling like you will pass out, dizziness, or feeling as if your heart is pounding or missing beats

• uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)

• metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain

• low blood pressure and fainting

• changes in your blood cell counts

• high level of prolactin in your blood (hyperprolactinemia). INVEGA TRINZA^® and INVEGA SUSTENNA^® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection

• problems thinking clearly and moving your body

• seizures

• difficulty swallowing that can cause food or liquid to get into your lungs

• prolonged or painful erection lasting more than 4 hours. Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours

• problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration

The most common side effects of INVEGA TRINZA^® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk.

The most common side effects of INVEGA SUSTENNA^® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling of inner restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA TRINZA^® or INVEGA SUSTENNA^®. For more information, ask your healthcare provider or pharmacist. 

General information about the safe and effective use of INVEGA TRINZA® or INVEGA SUSTENNA® 

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA TRINZA^® or INVEGA SUSTENNA^® for a condition for which it was not prescribed. Do not give INVEGA TRINZA^®or INVEGA SUSTENNA^® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about INVEGA TRINZA^® or INVEGA SUSTENNA^® that is written for healthcare professionals.

This Patient Information leaflet summarizes the most important information about INVEGA TRINZA^® and INVEGA SUSTENNA^®. If you would like more information, talk with your healthcare provider. 

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 of esketamine. 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 Research & Development, LLC 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; competition, including technological advances, new products and patents attained by competitors; challenges to patents; manufacturing difficulties and delays; changes in behavior and spending patterns or financial distress 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 description 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 January 1, 2017, including in Exhibit 99 thereto, 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 or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1. 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 March 2018).
2. World Health Organization. Depression. Available at: http://www.who.int/mediacentre/factsheets/fs369/en/. (Accessed March 2018).
3. Thase ME. Update on partial response in depression. J Clin Psychiatry. 2009;70[suppl 6]:4-9.
4. Ionescu, Dawn, et.al. "Pharmacological Approaches to the Challenge of Treatment Resistant Depression." Dialogues Clin Neurosci. 2015 Jun; 17(2): 111–126. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4518696/(Accessed April 2018).

Media Contact: 
Greg Panico 
609-730-3061 (office) 
908-240-2011 (mobile)

Investor Contacts: 
Joseph J. Wolk  
732-524-1142 (office)

Lesley Fishman  
732-524-3922 (office)

SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson