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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)

Schizophrenia: Data shows symptomatic patients treated with XEPLION benefit from initiation early within a hospital stay
Source: Schizophrenia News From Medical News Today [2015.06.18]
Janssen-Cilag International NV has announced results of the HOSPItal Use of Paliperidone Palmitate: A Prospective Non-Interventional Study (HOSPIPalm study) at the 12th World Congress of Biological...

Scientists identify schizophrenia's "Rosetta Stone" gene
Source: Mental Health News From Medical News Today [2015.07.24]
Scientists have identified a critical function of what they believe to be schizophrenia's "Rosetta Stone" gene that could hold the key to decoding the function of all genes involved in the disease.

High blood levels of growth factor correlate with smaller brain areas in patients with schizophrenia
Source: Schizophrenia News From Medical News Today [2015.07.16]
High blood levels of a growth factor known to enable new blood vessel development and brain cell protection correlate with a smaller size of brain areas key to complex thought, emotion and behavior...

Rexulti Approved for Schizophrenia, Depression
Source: MedicineNet Schizophrenia Specialty [2015.07.14]
Title: Rexulti Approved for Schizophrenia, Depression
Category: Health News
Created: 7/13/2015 12:00:00 AM
Last Editorial Review: 7/14/2015 12:00:00 AM

FDA approves REXULTI as adjunctive treatment for adults with major depressive disorder and as a treatment for adults with schizophrenia
Source: Schizophrenia News From Medical News Today [2015.07.13]
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) have announced that the U.S.

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...

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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.


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: 2015-07-24

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