Analysis of Longer-Term Clinical Study Suggests Psychiatric Hospitalization Rates Decreased in Adults with Schizophrenia Treated With INVEGA® SUSTENNA®

ORLANDO, Fla., Nov. 19, 2010 /PRNewswire/ -- Schizophrenia is a chronic and disabling brain disorder that affects 1 percent of the U.S. population and results in substantial medical and societal costs, in particular from use of health-care resources. It also can have devastating health-related and social effects on people with the disease, their families and caregivers.

A pre-specified analysis from a longer-term clinical study presented at the U.S. Psychiatric and Mental Health Congress today suggests that psychiatric hospitalization rates decreased for adults with schizophrenia who were treated with INVEGA® SUSTENNA® (paliperidone palmitate), a long-acting atypical antipsychotic for acute and maintenance treatment of schizophrenia in adults.

"This study suggests that INVEGA SUSTENNA may have potential to reduce psychiatric hospitalization rates," said Chris M. Kozma, PhD, independent researcher and adjunct professor, University of South Carolina, Columbia, and consultant for Ortho-McNeil Janssen Scientific Affairs, L.L.C., the sponsor of the study.  "While the results will need further investigation to confirm these observations, a treatment that can potentially lead to reduced hospitalizations for schizophrenia may offer economic benefits to health-care systems that pay for schizophrenia-related inpatient care."

Study Methods

Data for the analysis were from two phases of the clinical trial: a double-blind, randomized, relapse-prevention maintenance phase that compared INVEGA SUSTENNA to placebo and a one-year open-label extension of the study, during which all patients were treated with INVEGA SUSTENNA.

The change in schizophrenia-related hospitalization rates between the two phases of the study was evaluated for the group of patients treated with INVEGA SUSTENNA and for the group that received placebo. Data were obtained from an investigator-completed resource-use questionnaire. Overall change in hospitalization rates using all patients also was analyzed. A statistical analysis known as Poisson regression was used to evaluate changes in incidence of hospitalization over time and by the duration of each patient's schizophrenia diagnosis.

Results

There were 160 patients in the randomized INVEGA SUSTENNA-to-open label INVEGA SUSTENNA group and 153 patients in the randomized placebo-to-open label INVEGA SUSTENNA group.  The average age, gender and duration of schizophrenia diagnosis were similar at the start of the double blind phase for both groups. For the placebo group the average age was 38.5 years, 51 percent of the patients were male and 32 percent had schizophrenia for five or more years. For the INVEGA SUSTENNA group, the average age was 37.3 years, 51.9 percent were male and 30 percent has schizophrenia for five years or more.

During treatment with open-label INVEGA SUSTENNA, the number of hospitalizations per person-year for patients treated during the double-blind phase with placebo significantly declined from 0.27 to 0.06, or a 78 percent reduction (P<0.0047).  For those patients who were treated during the double-blind phase with INVEGA SUSTENNA and continued on INVEGA SUSTENNA during the open label phase, there was a decline in hospitalization rates from 0.11 to 0.04 (a 64 percent reduction, but this was not statistically significant (P<0.0758). Overall, the change in hospitalization rates from prior to initiation of treatment to the open label extension (n=381) produced similar results 0.35-0.04, or 89 percent reduction; P<0.0001.  It must be noted that this was an analysis of an exploratory objective and with that limitations apply to the observed results.  Additional investigations will be needed to confirm these observations and analyses.

This study was supported by Ortho-McNeil Janssen Scientific Affairs, L.L.C.

About 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.

IMPORTANT SAFETY INFORMATION FOR INVEGA® SUSTENNA®

INVEGA® SUSTENNA® (paliperidone palmitate) is used for the treatment of schizophrenia.

INVEGA® SUSTENNA® is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA® SUSTENNA® 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 INVEGA® SUSTENNA® 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 INVEGA® SUSTENNA® 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 INVEGA® SUSTENNA® 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 INVEGA® SUSTENNA® 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 INVEGA® SUSTENNA® 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.

INVEGA® SUSTENNA® 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.

INVEGA® SUSTENNA® 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.

INVEGA® SUSTENNA® can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA® SUSTENNA®, 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 INVEGA® SUSTENNA®. Please inform your healthcare professional of any medications or supplements that you are taking.

INVEGA® SUSTENNA® 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 INVEGA® SUSTENNA®.

Do not drink alcohol while you are taking INVEGA® SUSTENNA®.

In a study of people taking INVEGA® SUSTENNA®, 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 INVEGA® SUSTENNA® 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.

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

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