Topline Findings from Comparative Analysis of INVEGA(TM) and Quetiapine in Schizophrenia to be Postered at the 20th Annual U.S. Psychiatric and Mental Health Congress

Tuesday, October 9, 2007 General News
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TITUSVILLE, N.J., Oct. 8 Preliminary results from aclinical study comparing INVEGA(TM) (paliperidone) Extended-Release Tablets toquetiapine (marketed as Seroquel(R)) and placebo in patients with recent,acute exacerbation of schizophrenia will be the subject of a poster on displayduring the 20th Annual U.S. Psychiatric and Mental Health Congress, whichtakes place October 11-14, 2007 in Kissimmee, FL.

The poster, entitled "A Comparative Analysis of Paliperidone ER andQuetiapine in Patients With a Recent, Acute Exacerbation of Schizophrenia"will be on display on Saturday, Oct. 13 from 2:15 p.m. to 5:15 p.m. at theGaylord Palms Resort & Convention Center.

INVEGA is an atypical antipsychotic medication approved for acute andmaintenance treatment of patients with schizophrenia. Janssen, L.P, marketsINVEGA in the U.S.


INVEGA(TM) (paliperidone) extended-release tablets is indicated for theacute and maintenance treatment of schizophrenia.

Elderly Patients with dementia-related psychosis treated with atypicalantipsychotic drugs are at an increased risk of death compared to placebo.INVEGA (paliperidone) is not approved for the treatment of patients withdementia-related psychosis.

The most common side effects that occurred with INVEGA were restlessnessand extrapyramidal disorder (for example: involuntary movements, tremors andmuscle stiffness). One risk of INVEGA is that it may change your heartrhythm. This effect is potentially serious, and you should talk to your doctorabout any current or past heart problems. Some medications interact withINVEGA. Please inform your healthcare professional of any medications orsupplements that you are taking.

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

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effectreported with INVEGA and similar medications. TD includes uncontrollablemovements of the face, tongue, and other parts of the body. The risk ofdeveloping TD and the chance that it will become permanent is thought toincrease 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 itmay go away partially or completely if therapy is stopped.

INVEGA should be used cautiously in people with a seizure disorder, whohave had seizures in the past, or who have conditions that increase their riskfor seizures.

INVEGA and similar medications can raise the blood levels of a hormoneknown as prolactin, causing a condition known as hyperprolactinemia. Bloodlevels of prolactin remain elevated with continued use. Some side effects seenwith these medications include the absence of a menstrual period; breastsproducing milk; the development of breasts by males; and the inability toachieve an erection. The connection between prolactin levels and side effectsis unknown.

High blood sugar and diabetes have been reported with INVEGA and similarmedications. If the person being treated has diabetes or risk factors such asbeing overweight or a family history of diabetes, blood sugar testing shouldbe performed at the beginning and throughout treatment with INVEGA.Complications of diabetes can be serious and even life threatening. If signsof 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.

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