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Invega (Paliperidone) - Summary

 
 



Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks) in these subjects revealed a risk of death in the drug-treated subjects of between 1.6 to 1.7 times that seen in placebo-treated subjects. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated subjects was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. INVEGA™ (paliperidone) Extended-Release Tablets is not approved for the treatment of patients with dementia-related psychosis.

 

INVEGA SUMMARY

INVEGA™
(paliperidone)
Extended-Release Tablets

Paliperidone, the active ingredient in INVEGA™ Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA™ contains a racemic mixture of (+)- and (-)- paliperidone.

INVEGA™ (paliperidone) Extended-Release Tablets is indicated for the acute and maintenance treatment of schizophrenia.

The efficacy of INVEGA™ in the acute treatment of schizophrenia was established in three 6-week, placebo-controlled, fixed-dose trials in subjects with schizophrenia.

The longer-term benefit of maintaining schizophrenic patients on monotherapy with INVEGATM after achieving a responder status for 6 weeks was demonstrated in a controlled trial (see CLINICAL PHARMACOLOGY: Clinical Trials). The physician who elects to use paliperidone for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.


See all Invega indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Invega (Paliperidone)

Discovery of novel drug target may lead to better treatment for schizophrenia
Source: Psychology / Psychiatry News From Medical News Today [2014.12.12]
Scientists at the Centre for Addiction and Mental Health (CAMH) have identified a novel drug target that could lead to the development of better antipsychotic medications.Dr.

FDA Okays Aripiprazole for Acute Schizophrenia Relapse
Source: Medscape Psychiatry & Mental Health Headlines [2014.12.08]
The FDA has approved a labeling update for the long-acting injectable antipsychotic aripiprazole.
News Alerts

Study Finds Need for Improved Schizophrenia Care
Source: MedicineNet Schizophrenia Specialty [2014.12.04]
Title: Study Finds Need for Improved Schizophrenia Care
Category: Health News
Created: 12/4/2014 12:00:00 AM
Last Editorial Review: 12/4/2014 12:00:00 AM

Excess protein during brain development causes abnormalities and faulty connections in laboratory studies, may trigger schizophrenia
Source: Schizophrenia News From Medical News Today [2014.11.26]
A gene associated with schizophrenia plays a role in brain development and may help to explain the biological process of the disease, according to new Rutgers research.

Brain network vulnerable to Alzheimer's and schizophrenia identified
Source: MRI / PET / Ultrasound News From Medical News Today [2014.11.25]
A specific brain network within grey matter develops later than the rest of the brain and degenerates first in older age, says new study, shedding light on neurological disorders.

more news >>

Published Studies Related to Invega (Paliperidone)

Double-blind, placebo-controlled, pilot trial of paliperidone augmentation in serotonin reuptake inhibitor-resistant obsessive-compulsive disorder. [2013]
CONCLUSIONS: These results suggest that paliperidone augmentation is well

An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia. [2013]
The Food and Drug Administration recently approved Invega for the treatment of schizophrenia in adolescents 12 to 17 years. If dosing recommendations for this population would have been based only on the results of the single efficacy trial included in this program, paliperidone dosing in adolescents might have been limited to 3 mg/d in adolescents less than 51 kg and to 6 mg/d in adolescents greater than or equal to 51 kg...

Bilastine: in allergic rhinitis and urticaria. [2012]
Bilastine is an orally administered, second-generation antihistamine used in the symptomatic treatment of seasonal or perennial allergic rhinoconjunctivitis and urticaria. In two well designed phase III trials, 14 days' treatment with bilastine was associated with a significantly lower area under the effect curve (AUEC) for the reflective total symptom score (TSS) than placebo in patients with symptomatic seasonal allergic rhinitis...

A randomized, placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode. [2012]
patients with this disorder... CONCLUSIONS: Paliperidone ER significantly delayed the time to recurrence of any

Oral paliperidone: a review of its use in the management of schizoaffective disorder. [2011.06.01]
Oral paliperidone extended or prolonged release (Invega(R)) is an atypical antipsychotic, and is the first agent approved for the treatment of schizoaffective disorder. Paliperidone (or 9-hydroxyrisperidone) is the major active metabolite of the well known atypical antipsychotic risperidone, and its mechanism of action is thought to be the antagonism of dopamine D(2) and serotonin 5-HT(2A) receptors...

more studies >>

Clinical Trials Related to Invega (Paliperidone)

Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism [Not yet recruiting]
Our primary specific aim is to examine the efficacy of Paliperidone extended release Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) compared to placebo in decreasing manic symptoms in patients with comorbid DSM-IV bipolar disorder and alcohol dependence. We hypothesize that the Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) treated group will have a statistically significant advantage on improvement in manic symptoms. They will also have higher rate of treatment response and remission.

A Study to Evaluate the Response to Treatment and Safety of Flexible Dose Treatment With Extended-release Paliperidone in Patients With Schizophrenia [Recruiting]
This study will explore the efficacy and safety of flexibly dosed paliperidone ER in subjects with schizophrenia.

Hypothesis:

At the end of 12 months, flexible dose paliperidone treatment is expected to improve functionality and satisfaction of schizophrenia patients significantly as measured by PSP. The expected increase in PSP score is approximately 10-20%

Invega for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder [Recruiting]
This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. Specific hypotheses are as follows:

Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.

Hypothesis 2: Invega - associated improvement in bipolar disorder symptomatology in children

and adolescents will translate into improved functional capacities (neuropsychological, social, and occupational), as well as an increased quality of life throughout treatment.

Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out rate and absence of major side effects.

Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia [Recruiting]
Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia.

Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone

A Study of Paliperidone Palmitate in Patients With Schizophrenia [Recruiting]
The primary objective of this study is to evaluate the efficacy of paliperidone palmitate as compared with placebo in patients with schizophrenia. Secondary objectives of this study are to evaluate the safety of paliperidone palmitate; to evaluate the improvement in global

symptoms as measured by the Clinical Global Impression - Severity (CGI-S) associated with

the use of paliperidone palmitate compared with placebo; and to explore the pharmacokinetics of paliperidone palmitate through pharmacokinetic sampling.

more trials >>

Reports of Suspected Invega (Paliperidone) Side Effects

Extrapyramidal Disorder (31)Drug Ineffective (30)Depression (28)Weight Increased (27)Dystonia (24)Insomnia (23)Pain (22)Somnolence (22)Abnormal Behaviour (22)Tardive Dyskinesia (22)more >>


Page last updated: 2014-12-12

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