New Data on INVEGA(R) SUSTENNA(R) and RISPERDAL(R) CONSTA(R) for Schizophrenia to be Presented at Major Psychiatry Meeting

Monday, May 24, 2010 General News
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TITUSVILLE, N.J., May 24 New data on INVEGAŽ SUSTENNAŽ (paliperidone palmitate), a long-acting injectable medicine for schizophrenia, and new data on RISPERDALŽ CONSTAŽ (risperidone long-acting therapy), also an injectable medicine to treat schizophrenia, will be presented this week at a major psychiatry meeting in New Orleans. Posters on this data will be presented on Wednesday, May 26, from 12 noon to 2 pm at the meeting.

The posters address topics such as efficacy in different populations of patients with schizophrenia; long-term pharmacokinetics and long-term safety; and pharmacoeconomics.

Ortho-McNeil Janssen Scientific Affairs, L.L.C. or Johnson & Johnson Pharmaceutical Research & Development, L.L.C. supported this research:

Poster NR6-17: Effects of Paliperidone Palmitate Treatment in Schizophrenia Patients Previously Treated with Oral Risperidone

Poster NR6-26: Effects of Paliperidone Palmitate in Acutely Ill Subjects with a Marked-to-Severe Exacerbation of Schizophrenia

Poster NR6-21: Tolerability of Paliperidone Palmitate Initiation Doses in Subjects with Recently Diagnosed Schizophrenia

Poster NR6-5: Onset of Efficacy with Paliperidone Palmitate in Patients with Acutely Exacerbated Schizophrenia

Poster NR6-7: Long-Term Safety, Tolerability And Pharmacokinetics of Paliperidone Palmitate: A One-Year, Open-Label Study in Patients with Schizophrenia

Poster NR6-12: A Randomized Double-Blind, Comparative Study of Paliperidone Palmitate and Risperidone Long-Acting Therapy in Patients with Schizophrenia

Poster NR6-34: Efficacy of Long-Acting Risperidone in Patients with Schizophrenia : A Six-Month Follow Up from the E-Star Database in Latin America

Poster NR6-25 : Cost-Effectiveness of Paliperidone Palmitate Versus Oral Atypicals and a Conventional Depot Formulation in the United States

IMPORTANT SAFETY INFORMATION FOR INVEGAŽ SUSTENNAŽ

INVEGAŽ SUSTENNAŽ (paliperidone palmitate) is used for the treatment of schizophrenia.

INVEGAŽ SUSTENNAŽ is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGAŽ SUSTENNAŽ in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.

Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGAŽ SUSTENNAŽ and similar medicines. Call the doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.

Tardive Dyskinesia (TD) is a rare, but serious and sometimes permanent side effect reported with INVEGAŽ SUSTENNAŽ and similar medicines. Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the total dose received. This condition can also develop after a short period of treatment at low doses but this is less common. There is no known treatment for TD but it may go away partially or completely if the medicine is stopped.

One risk of INVEGAŽ SUSTENNAŽ is that it may change your heart rhythm. This effect is potentially serious. You should talk to your doctor about any current or past heart problems. Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).

High blood sugar and diabetes have been reported with INVEGAŽ SUSTENNAŽ and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or "pass urine" more often than usual, or feeling weak or hungry.

Weight gain has been observed with INVEGAŽ SUSTENNAŽ and other atypical antipsychotic medications. If you notice that you are gaining weight, please notify your doctor.

Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly. It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.

INVEGAŽ SUSTENNAŽ and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.

INVEGAŽ SUSTENNAŽ and similar medicines can raise the blood levels of a hormone called prolactin and blood levels of prolactin remain high with continued use. This may result in some side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.

If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.

INVEGAŽ SUSTENNAŽ can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGAŽ SUSTENNAŽ, be careful driving a car, operating machines, or doing things that require you to be alert.

This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.

Some medications interact with INVEGAŽ SUSTENNAŽ. Please inform your healthcare professional of any medications or supplements that you are taking.

INVEGAŽ SUSTENNAŽ should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with INVEGAŽ SUSTENNAŽ.

Do not drink alcohol while you are taking INVEGAŽ SUSTENNAŽ.

In a study of people taking INVEGAŽ SUSTENNAŽ, common side effects in the treatment of schizophrenia were reactions at the injection site, sleepiness, dizziness, feeling of inner restlessness, and abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes.

This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.

If you have any questions about INVEGAŽ SUSTENNAŽ or your therapy, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information.

RISPERDALŽ CONSTAŽ (risperidone) is used for the treatment of schizophrenia and for the longer-term treatment of Bipolar I Disorder .

IMPORTANT SAFETY INFORMATION FOR RISPERDALŽ CONSTAŽ

Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDALŽ CONSTAŽ (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDALŽ CONSTAŽ and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDALŽ CONSTAŽ and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

High blood sugar and diabetes have been reported with RISPERDALŽ CONSTAŽ and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with RISPERDALŽ CONSTAŽ. Complications of diabetes can be serious and even life-threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

RISPERDALŽ CONSTAŽ and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.

Some people taking RISPERDALŽ CONSTAŽ may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect can be reduced or it may go away over time.

Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with RISPERDALŽ CONSTAŽ .

RISPERDALŽ CONSTAŽ may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

RISPERDALŽ CONSTAŽ should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Painful, long-lasting erections have been reported with the use of RISPERDALŽ CONSTAŽ . Call your doctor immediately if you think you are having this problem.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDALŽ CONSTAŽ . Caution should be used when administering RISPERDALŽ CONSTAŽ to a nursing woman.

RISPERDALŽ CONSTAŽ may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Some medications interact with RISPERDALŽ CONSTAŽ . Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDALŽ CONSTAŽ.

In a study of people taking RISPERDALŽ CONSTAŽ , the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

In a study of people taking RISPERDALŽ CONSTAŽ , the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and tremors (when used with lithium or valproate).

If you have any questions about RISPERDALŽ CONSTAŽ or your therapy, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more information about RISPERDALŽ CONSTAŽ, please read the Important Product Information.

Ortho-McNeil Janssen Scientific Affairs, L.L.C.

Ortho-McNeil Janssen Scientific Affairs, L.L.C., is a member of the Johnson & Johnson family of companies. Johnson & Johnson is the world's largest manufacturer of healthcare products serving the consumer, pharmaceutical and professional markets.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)

J&JPRD is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

Media contact: Greg Panico 908-240-2011 Investor Relations: Lesley Fishman 732-524-3922

SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc.


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