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Invega (Paliperidone) - Summary

 
 



WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients 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. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. INVEGA® (paliperidone) Extended-Release Tablets is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions]

 

INVEGA SUMMARY

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.

Schizophrenia

INVEGA® (paliperidone) Extended-Release Tablets are indicated for the treatment of schizophrenia [see Clinical Studies].

The efficacy of INVEGA® in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.

Schizoaffective Disorder

INVEGA® (paliperidone) Extended-Release Tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies].

The efficacy of INVEGA® in schizoaffective disorder was established in two 6-week trials in adults.


See all Invega indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Invega (Paliperidone)

Smoking and schizophrenia: understanding and breaking the cycle of addiction
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2016.04.18]
Smoking addiction in schizophrenia can be explained by significantly increased activation of the ventro-medial prefrontal cortex (vmPFC), a region involved in the brain reward system.

For young people with schizophrenia, physical and mental exercises offer hope
Source: Schizophrenia News From Medical News Today [2016.04.07]
Workouts appear to trigger 'Miracle-Gro for the brain' that restores connections between neurons, UCLA researchers find.

Decrypting a collagen's role in schizophrenia
Source: Epilepsy News From Medical News Today [2016.03.15]
A small peptide generated from a collagen protein may protect the brain from schizophrenia by promoting the formation of neuronal synapses, according to a paper published in The Journal of Cell...

Rare mutations in single gene associated with schizophrenia
Source: Schizophrenia News From Medical News Today [2016.03.15]
Mutations in a single gene that increase risk of schizophrenia and other neurodevelopmental disorders are reported in a study published online in Nature Neuroscience.

New studies of the 'natural history' of schizophrenia raise hope for new treatments
Source: Schizophrenia News From Medical News Today [2016.03.11]
Emerging evidence on the development, "prodromal" characteristics, and long-term course of schizophrenia provide reasons for optimism for developing new treatments and preventive approaches for...

more news >>

Published Studies Related to Invega (Paliperidone)

Estimated medical cost reductions for paliperidone palmitate vs placebo in a randomized, double-blind relapse-prevention trial of patients with schizoaffective disorder. [2015]
CONCLUSIONS: Use of PP1M for treatment of patients with schizoaffective disorder

Paliperidone palmitate once-monthly reduces risk of relapse of psychotic, depressive, and manic symptoms and maintains functioning in a double-blind, randomized study of schizoaffective disorder. [2015]
CONCLUSIONS: Paliperidone monthly as monotherapy or adjunctive therapy

Relapse prevention study of paliperidone extended-release tablets in Chinese patients with schizophrenia. [2014]
patients with schizophrenia... CONCLUSIONS: This study confirms the findings from earlier pali ER global

Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. [2014]
antipsychotics in markedly-to-severely ill schizophrenia subjects... CONCLUSIONS: Using the recommended dosing regimens for PP and RLAI, both PP and

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

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Clinical Trials Related to Invega (Paliperidone)

Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning [Recruiting]
The purpose of this study is to better understand brain function and psychiatric and neurological illness when taking Invega or Risperdal. The objective is to compare the brain effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be evaluated with PET imaging, fMRI, and neurological ratings and assessments.

The Paliperidone ER Observational Study of Economic, Functional, and Clinical Outcomes in Patients With Schizophrenia [Terminated]
The purpose of this study is to examine the long-term economic, functional and clinical outcomes in schizophrenia patients who require a change in antipsychotic treatment, and are changed to either paliperidone extended release (ER) or another oral atypical antipsychotic agent (AAP) including aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone.

Paliperidone ER(Invega) on Depressive Symptoms of Schizophrenia Patients [Recruiting]

A Comparative Study to Evaluate the Evolution of Medication Satisfaction and Adherence in Patients Unsatisfied With Current Oral Atypical Antipsychotics by Switching Medication to Paliperidone Palmitate [Completed]
The purpose of this study is to evaluate the change of medication satisfaction measured by Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode.

A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia [Completed]
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

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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: 2016-04-18

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