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Patients Treated with Risperidone Long-Acting Injection had a Significantly Longer Time to Relapse Compared to Quetiapine in International Clinical Study

Separate Study Showed Significantly Improved Functioning Within Three Months

WASHINGTON, May 06, 2008 /PRNewswire-FirstCall/ -- Nearly half of patients with schizophrenia fail to remain on their medication treatment, which can result in a relapse of symptoms (1,2). Today, data from a new international study showed that patients treated with risperidone long-acting injection (RLAI) had a significantly longer time to relapse (3) compared to patients treated with an oral atypical medication, quetiapine.

The results were presented today for the first time at the American Psychiatric Association (APA) 161st Annual Meeting in Washington, D.C.

This 24-month, open-label, active-controlled, comparative international study, was the largest since the 1979 Hogarty study(4) to compare the relapse rates of a long-acting injectable antipsychotic and an oral medication. The objective of the trial was to compare longer-term maintenance therapy of patients with schizophrenia or other related disorders (schizoaffective disorder) treated with RLAI or quetiapine.

"This study provides compelling evidence that RLAI offers a significant benefit to people with schizophrenia in delaying the time to relapse," said Professor Wolfgang Gaebel from the Department of Psychiatry and Psychotherapy at the Heinrich-Heine University in Dusseldorf, Germany and one of the study investigators.

This international study, which enrolled 710 patients (355 randomized to received RLAI [mean dose 32.75 mg] and 355 to receive quetiapine [mean dose 397 mg]), investigated whether treatment with RLAI compared with oral quetiapine, when tested in a routine care setting within general psychiatric services, had an effect on long-term efficacy maintenance as measured by time to relapse.(5)

Results demonstrated that the average relapse-free time was significantly longer in patients treated with RLAI (607 days) compared with quetiapine (533 days), p<0.0001. Furthermore, over the 24-month treatment period, relapse occurred in 16.5 percent of patients treated with RLAI and 31.3 percent in the quetiapine treatment arm.(6)

Both RLAI and quetiapine had generally comparable safety profiles. Extrapyramidal symptoms (EPS) attributed to medication were observed in 10 percent of the patients receiving RLAI and in six percent of the patients in the quetiapine group. Weight gain was observed in both treatment arms with no statistically significant differences in changes in body weight or BMI versus baseline (seven percent weight gain for RLAI versus 6.2 percent for quetiapine). Potentially prolactin-related adverse events were observed in 16.7 percent of the patients in the RLAI arm and in three percent of patients in the quetiapine arm.

Reasons for withdrawing from the study, other than relapse, were equivalent in both treatment groups except that more withdrawals due to non-compliance/refusing injection were reported for RLAI (three percent) than quetiapine (one percent). The most common serious adverse events were psychiatric symptoms (15 percent with RLAI and 18 percent with quetiapine). Death occurred in three patients treated with RLAI and two with quetiapine. None of the deaths were considered to be possibly or probably related to study drug.

The study was sponsored by Janssen-Cilag, Medical Affairs EMEA.

Separately, an interim analysis from a two-year U.S. observational study also presented today at APA showed patients taking RLAI had significantly improved functioning within three months after starting treatment. That study enrolled 532 patients from 66 community health centers and Veterans Affairs centers in the United States. Data collection occurred at baseline (month 0) and then every three months up to the two years. At the time of this interim analysis, 107 patients had completed the full two-year period.(7)

The U.S. interim analysis showed an overall significant improvement in patient functioning from serious to occasional impairments following initiation of RLAI (p<0.001); and 11 percent more patients reported they were "very" or "extremely" satisfied with their current antipsychotic therapy at the first visit after the initiation of treatment with RLAI compared to their first visit prior to the initiation of RLAI.

There were several limitations to the trial that preclude definitive conclusions from being made. Therefore, the results may not be generalized to other populations and additional studies will be needed to confirm this analysis.

The study was sponsored Ortho-McNeil Janssen Scientific Affairs, LLC.

About Schizophrenia

An estimated one percent of the world's population suffers from schizophrenia -- a brain disorder that impairs a person's ability to think clearly, relate to others and distinguish between reality and imagination. It typically develops in adolescence or the early twenties, although symptoms may not become immediately obvious.

About Risperidone Long-Acting Injection

Risperidone long-acting injection (RLAI) is a long-acting injectable atypical antipsychotic medication used for the treatment of schizophrenia. RLAI is marketed by Janssen-Cilag outside of the U.S. and Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. It is manufactured by Alkermes, Inc.

IMPORTANT SAFETY INFORMATION FOR RISPERIDONE AND RISPERIDONE LONG-ACTING INJECTION (RLAI)

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Risperidone and RLAI are not approved for the treatment of patients with dementia-related psychosis.

The most common adverse reactions observed in all clinical trials with risperidone occurring at a rate of at least 10 percent were somnolence, increased appetite, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, increased saliva, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and indigestion.

The most common side effects that occurred with RLAI were sleepiness, restlessness, tremors and muscle stiffness, stomach upset, constipation, dry mouth, feeling tired, and weight increase.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with risperidone, RLAI, 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 risperidone, RLAI, 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.

Risperidone and RLAI 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.

Risperidone, RLAI, 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.

High blood sugar and diabetes have been reported with risperidone, RLAI, 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. 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.

Some people taking risperidone or RLAI 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.

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.

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

Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking risperidone or RLAI. Do not breast-feed if you are taking risperidone or RLAI.

Risperidone and RLAI may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

Risperidone and RLAI may affect alertness and motor skills; use caution until the effect of risperidone or RLAI is known.

(1)Leucht S, Heres S. Epidemiology, clinical consequences, and psychosocial treatment of nonadherence in schizophrenia. J Clin Psychiatry 2006;67 (Suppl 5):3-8.

(2)Rosa MA, Marcolin MA, Elkis H. Evaluation of the factors interfering with drug treatment compliance among Brazilian patients with schizophrenia. Rev Bras Psiquiatr 2005;27:78-84.

(3)Relapse diagnosed if subjects met any of the following criteria on 2 consecutive evaluations conducted 3-5 days apart: Psychiatric hospitalization; Increase in level of care necessary AND .25 percent increase in PANSS total score from baseline or an increase of 10 points if the baseline score was .40; Significant clinical deterioration defined as a CGI-C score of 6 (much worse); Deliberate self-injury; Emergence of clinically significant suicidal or homicidal ideation; Violent behavior resulting in significant injury to another person or property; Exceeding the registered dose of the drug

(4)Hogarty GE, Schooler NR, Ulrich R et al. Arch Gen Psychiatry 1979;36:1283-94

(5)Medori R, Wapenaar R, de Arce R et al. Relapse Prevention and Effectiveness in Schizophrenia with Risperidone Long-Acting Injectable (RLAI) Versus Quetiapine. Poster presented at 161st Annual American Psychiatric Association Meeting, 2008, Washington, USA

(6)In this study, a small number of patients were randomized to aripiprazole for exploratory purposes only. The descriptive efficacy and safety analysis of these patients will be presented separately.

(7)Concetta C, Mao L, Kosma C et al., Evaluation of effectiveness measures for patients with schizophrenia who initiated therapy with risperidone long- acting injectable, presented at the 161st Annual Meeting of the American Psychiatry Association (APA), Washington, DC.

CONTACT: Media: Ambre Morley in the U.S., +1-908-507-0160 (mobile phone);or Sue Silk of Janssen-Cilag, +44-7774-173990; or Investors: LouiseMehrotra, +1-732-524-6491, or Lesley Fishman, +1-732-524-3922, both ofJohnson & Johnson

Web site: http://www.jnj.com/

Ticker Symbol: (:JNJ)

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Posted: May 2008

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