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Invega Sustenna (Paliperidone Palmitate) - Summary



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® SUSTENNA® (paliperidone palmitate) is not approved for the treatment of patients with dementia-related psychosis. [See Warnings and Precautions]



INVEGA® SUSTENNA® contains paliperidone palmitate. The active ingredient, paliperidone palmitate, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives.

INVEGA® SUSTENNA® (paliperidone palmitate) is indicated for the acute and maintenance treatment of schizophrenia in adults [see Clinical Studies].

See all Invega Sustenna indications & dosage >>


Media Articles Related to Invega Sustenna (Paliperidone)

Structural brain connectivity as a genetic marker for schizophrenia
Source: Genetics News From Medical News Today [2015.11.25]
Schizophrenia has been considered an illness of disrupted brain connectivity since its earliest descriptions.

Neurological underpinnings of schizophrenia just as complex as the disorder itself
Source: Neurology / Neuroscience News From Medical News Today [2015.11.25]
New analysis links cognitive, emotional, and intellectual symptoms to neurological 'disruption' in multiple brain regions - a finding with important implications for diagnosis and treatment.

Autifony Therapeutics initiates Phase I study of AUT00206, a novel treatment approach for schizophrenia
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.11.24]
Autifony Therapeutics Limited, which is pioneering the development of novel pharmaceutical treatments for hearing loss and other serious brain disorders, today announced the start of Phase I...

Brain Differences May Explain Why Some With Schizophrenia Hallucinate
Source: MedicineNet Schizophrenia Specialty [2015.11.18]
Title: Brain Differences May Explain Why Some With Schizophrenia Hallucinate
Category: Health News
Created: 11/17/2015 12:00:00 AM
Last Editorial Review: 11/18/2015 12:00:00 AM

Database translates schizophrenia research into one 'language'
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.11.11]
SchizConnect, a new meta-database that translates all clinical schizophrenia studies into a single scientific "language," has been launched to help researchers long stymied by inconsistent findings...

more news >>

Published Studies Related to Invega Sustenna (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 Sustenna (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 Sustenna (Paliperidone) Side Effects

Drug Dose Omission (179)Device Leakage (78)Drug Ineffective (77)Weight Increased (72)Product Quality Issue (61)Condition Aggravated (53)Psychotic Disorder (48)Inappropriate Schedule of Drug Administration (47)Injection Site Pain (47)Hospitalisation (44)more >>

Page last updated: 2015-11-25

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