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

 

SUMMARY

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 >>

NEWS HIGHLIGHTS

Media Articles Related to Invega Sustenna (Paliperidone)

Study shows INVEGA SUSTENNA effective six months longer than common oral antipsychotics in treatment of schizophrenia
Source: Schizophrenia News From Medical News Today [2015.04.17]
A study published in The Journal of Clinical Psychiatry shows that long-acting INVEGA SUSTENNA® (paliperidone palmitate) was effective six months longer than commonly prescribed oral...

FDA OKs 3-Month Paliperidone Injection for Schizophrenia
Source: Medscape Psychiatry & Mental Health Headlines [2015.05.19]
The quarterly treatment for schizophrenia must be preceded by monthly injections of Invega Sustenna for at least 4 months.
FDA Approvals

New study found three-month paliperidone palmitate significantly delayed time to relapse in patients with schizophrenia
Source: Schizophrenia News From Medical News Today [2015.04.01]
Three-month paliperidone palmitate, an investigational atypical antipsychotic, significantly delayed time to relapse compared to placebo in patients with schizophrenia, according to a new Phase 3...

Results announced from the QUALIFY study in schizophrenia
Source: Schizophrenia News From Medical News Today [2015.03.31]
Otsuka Pharmaceutical Europe Ltd. presented the results of the QUALIFY* study, which showed the superiority of Abilify Maintena compared to paliperidone palmitate when using the Heinrichs-Carpenter...

How a schizophrenia risk gene affects the brain
Source: Genetics News From Medical News Today [2015.05.22]
Scientists have for the first time shown how the disruption of a key gene involved in mental illness impacts on the brain.

more news >>

Published Studies Related to Invega Sustenna (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 Sustenna (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 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: 2015-05-22

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