Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder

San Diego, Calif. (April 1, 2009) - Patients with schizoaffective disorder who received paliperidone extended release tablets (paliperidone ER) for six weeks showed significant improvement in a broad range of schizoaffective symptoms, according to a new study presented today at the 12th International Congress on Schizophrenia Research (ICOSR) in San Diego, Calif. The findings of the study provide additional evidence for symptomatic improvement of schizoaffective disorder following therapy with paliperidone ER.

"This well-designed and conducted study of paliperidone ER in patients with schizoaffective disorder found that this medication is both efficacious and well-tolerated," said Nina Schooler, Ph.D., SUNY Downstate Medical Center. "These new data support the potential use of paliperidone ER as an effective option for the treatment of this understudied group of patients."

Schizoaffective disorder is a condition, which encompasses the symptoms of both schizophrenia and a major mood disorder. Patients with schizoaffective disorder experience the psychosis characteristic of schizophrenia, such as hallucinations or delusions, as well as symptoms of mania and/or depression. Schizoaffective disorder can be difficult to distinguish from schizophrenia or bipolar disorder because the symptoms are similar to both. The disorder is about one third as common as schizophrenia but within those people that frequently use mental health services, schizophrenia and schizoaffective disorder may account for approximately 32% and 24% of cases respectively.

In the six week, international, randomized, double-blind, placebo controlled study, 311 patients with an established diagnosis of schizoaffective disorder, who were experiencing acute symptoms, were randomized to receive either paliperidone ER or a placebo. The paliperidone ER dose was initiated at 6 mg/day and could be adjusted in range from 3mg/day to 12mg/day up to day 15, after which no dose adjustments were allowed. In addition to study medication, subjects were permitted to receive concomitant treatment with an antidepressant and/or mood stabilizer, provided these medications had been given at a stable dose within 30 days of screening. Approximately half the subjects enrolled received ongoing treatment with an antidepressant and/or mood stabilizer during the study.

Based on the primary outcome parameter of change in PANSS total score from baseline to week 6 endpoint results showed that patients in the paliperidone ER group had significantly greater improvement as compared to patients on placebo (p=0.001). Changes were also noted in many secondary outcomes parameters measured in the trial. The paliperidone ER group exhibited a significant improvement in mean Clinical Global Impressions of Severity for Schizoaffective Disorder (CGI-S-SCA) scores when compared to patients taking placebo (p=0.002). Further, among patients with prominent manic symptoms as measured by the Young Mania Ratings Scale (YMRS score ≥16) paliperidone ER exhibited significant improvement compared to placebo on the YMRS (p=0.001). Likewise, among patients with prominent depressive symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D-21 score ≥16), paliperidone ER exhibited significant improvements compared to placebo on the HAM-D-21 (p<0.001).

The most common adverse events occurring in this trial were: headache (32%), dizziness (18%), insomnia (14%), akathisia (13%) and dyspepsia (12%).

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

Paliperidone ER, an atypical antipsychotic medication, was first approved in the U.S. in December 2006. Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., markets paliperidone ER as INVEGA(R). 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.

In February 2009, two supplemental new drug applications (sNDAs) were submitted to the FDA requesting approval for the use of paliperidone ER for the treatment of schizoaffective disorder as monotherapy and for use in combination with antidepressants and/or mood stabilizers. If approved by the FDA, INVEGA would be the only medication indicated to treat the condition.

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. It has 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.

Ortho-McNeil Janssen Scientific Affairs, LLC, and Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., are part of the Johnson & Johnson family of companies.

IMPORTANT SAFETY INFORMATION FOR INVEGA(R)

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA(R) (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 INVEGA(R) 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 INVEGA(R) 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 INVEGA(R). 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 INVEGA(R) 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 INVEGA(R) 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 INVEGA(R). 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.

INVEGA(R) 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 INVEGA(R).

Some people taking INVEGA(R) 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.

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

INVEGA(R) 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 INVEGA(R). Caution should be exercised when INVEGA(R) is administered to a nursing woman.

INVEGA(R) may affect alertness and motor skills; use caution until the effect of INVEGA(R) is known.

INVEGA(R) 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.

INVEGA(R) 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 INVEGA(R) were restlessness and extrapyramidal disorder (for example, involuntary movements, tremors and muscle stiffness).

Note Regarding Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Janssen and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.

 

 

Posted: April 2009

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