Washington, DC. May 7, 2008 – Patients receiving paliperidone extended release tablets (paliperidone ER) spent significantly fewer days in the hospital, had significantly fewer emergency room and psychiatric-related office visits, and fewer psychotherapy sessions, compared with the year before starting on paliperidone ER, according to a new analysis of data presented at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington DC ¹ .

In the analysis, researchers retrospectively reviewed the charts of 79 of the patients who had participated in any of three multi-center, double-blind, randomized six-week trials of paliperidone ER and placebo, and were then entered into a 12-month open-label extension (OLE) phase. The investigators compared the number of days a patient was hospitalized for psychiatric reasons in the 12 months before being screened for the trial (pre-period) with those in the 12-month OLE phase (post-period) following administration of the first dose of paliperidone ER. ² Most of the patients (70.9%) had received prior antipsychotic medication during the pre-period.

The results showed that patients taking paliperidone ER used significantly fewer healthcare resources after starting on the medication than in the one year period before entering the trials.  Patients had an average of 12 fewer hospital days (p=0.002), 0.3 fewer emergency room visits (p=0.038), two fewer psychiatric-related office visits (p<0.001) and 0.4 fewer psychotherapy sessions (p=0.004).

An economic analysis showed that the average costs savings for the reduced resource use with paliperidone ER was $7,411 per person-year, based on current Federal Medicare per diem base rates and 2007 Medicare unit costs, taking into account psychiatric-related hospitalizations, emergency room visits, psychiatric-related clinic visits and psychotherapy.

“Due to its chronic nature and the need for frequent hospitalization, schizophrenia is associated with significant economic burden,” said Dr. Philip Janicak, Professor of Psychiatry, Rush University Medical Center and one of the lead investigators in the trial. ^b   “Treating physicians, patients and their families would welcome treatment options that may help reduce resource use.”

“We should keep in mind, important study limitations include the lack of a control group; pre-post design comparing historical data with data collected in the trials could create a bias due to the mismatch in settings; and patients may have had more frequent contact with treating physicians and investigators during the trial period which could favor the outcomes in the open-label phase. Therefore prospective studies should be conducted to confirm these findings.”

A separate post-hoc analysis from those same three OLE studies also presented today examined employment status of patients with schizophrenia treated with paliperidone ER over the 52-week OLE period. A total of 1012 patients 18 years and older with a diagnosis of schizophrenia were included. At their first and last visits, patients were placed into nine different occupational status categories.

The percentage of patients who reported employment during the open-label phase of the study increased throughout the 52-week study period. The number of patients who were employed full-time at their last visit almost doubled from 4.8 percent at the first visit to 8.8 percent, and the number of patients in any form of employment (including students, but excluding housewives or those retired) increased by 10.6 percent.

The studies were sponsored by Ortho-McNeil Janssen Scientific Affairs, LLC. Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. markets paliperidone ER in the U.S.

Paliperidone ER, an atypical antipsychotic medication, was first approved in the U.S. in December 2006. It is approved for the acute and maintenance treatment of schizophrenia in the U.S. and for the treatment of schizophrenia in the E.U.

Worldwide, it is estimated that 1 person in every 100 develops schizophrenia ² , one of the most serious types of mental illness. An estimated 2.4 million Americans have schizophrenia, with men and women affected equally ³ .  The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well by disorganized thinking, speech and behavior.

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. As the company celebrates its 50th year in mental health, it currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder.  For more information about Janssen, visit http://www.janssen.com.

IMPORTANT SAFETY INFORMATION FOR PALIPERIDONE

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Paliperidone 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 paliperidone 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.

One risk of paliperidone is that it may change your heart rhythm. This effect is potentially serious, and you should talk to your doctor about any current or past heart problems. Some medications interact with paliperidone. Please inform your healthcare professional of any medications or supplements that you are taking.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with paliperidone 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 paliperidone 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 paliperidone. 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.

Paliperidone 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. The connection between prolactin levels and side effects is unknown.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach or small or large intestine) should talk to their healthcare professional before taking paliperidone.
Some people taking paliperidone 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 may be reduced or it may go away over time.

Paliperidone may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional. Avoid alcohol while on paliperidone.

Paliperidone 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.

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 are pregnant or if you are planning to get pregnant while taking paliperidone. Caution should be exercised when paliperidone is administered to a nursing woman.

Paliperidone may affect alertness and motor skills; use caution until the effect of paliperidone is known.

Paliperidone 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.

Paliperidone should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.

The most common side effects that occurred with paliperidone were restlessness and extrapyramidal disorder (for example, involuntary movements, tremors and muscle stiffness).

^a Because only 28 percent of patients completed the entire 12-month OLE phase, total person-years were calculated for the post-period to account for different lengths of observation compared with the pre-period.
^b Dr. Janicak is a consultant to Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

References
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¹ Janicak P, Wu J, Amatniek J et al., Changes in mental health resource use after initiation of paliperidone ER in patients with schizophrenia, presented at the 161st Annual Meeting of the American Psychiatry Association (APA), Washington, DC.
² Royal College of Psychiatrists website: http://www.rcpsych.ac.uk/default.aspx?page=1643 Accessed April 14, 2008
³ American Psychiatric Association. Let’s talk facts about schizophrenia. Available at: http://healthyminds.org/factsheets/LTF-Schizophrenia.pdf Accessed April 1, 2008.