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Fanapt (Iloperidone) - 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. Analysis of seventeen placebo-controlled trials (modal duration 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the 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. FANAPT is not approved for the treatment of patients with Dementia-Related Psychosis. [See Warnings and Precautions]

 

FANAPT SUMMARY

FANAPT is a psychotropic agent belonging to the chemical class of piperidinyl-benzisoxazole derivatives.  Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3' -methoxyacetophenone.

FANAPT® tablets are indicated for the treatment of adults with schizophrenia. Efficacy was established in two short-term (4- and 6-week) placebo- and active-controlled studies of adult patients with schizophrenia [see Clinical Studies].

When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that FANAPT is associated with prolongation of the QTc interval [see Warnings and Precaution s ]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether FANAPT will cause torsade de pointes or increase the rate of sudden death is not yet known.

Patients must be titrated to an effective dose of FANAPT. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia [s ee Dosage and Administration and Clinical Studies].

The effectiveness of FANAPT in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use FANAPT for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration].


See all Fanapt indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Fanapt (Iloperidone)

Long-term safety and tolerability of iloperidone: results from a 25-week, open-label extension trial. [2013]
placebo- and ziprasidone-controlled clinical trial of iloperidone... CONCLUSION: This study further supports the long-term safety and

Iloperidone: in schizophrenia. [2009]
Iloperidone is an atypical antipsychotic that is approved for the treatment of adult patients with schizophrenia. In several large (n > 570 per trial), 4- or 6-week, double-blind, multinational, multicentre trials in adult patients with schizophrenia, recommended target dosages of oral iloperidone (6-12 mg twice daily) generally showed better efficacy than placebo, in terms of improvements in Positive and Negative Syndrome Scale (PANSS) total scores or Brief Psychiatric Rating Scale (BPRS) scores (primary endpoints) and also for most secondary endpoints, including PANSS subscale scores.

Iloperidone for schizophrenia: a review of the efficacy and safety profile for this newly commercialised second-generation antipsychotic. [2009]
CONCLUSIONS: Aside from paliperidone, iloperidone is the first new

Applicability of a genetic signature for enhanced iloperidone efficacy in the treatment of schizophrenia. [2009]
CONCLUSION: These results illustrate the combined use of genetic markers to

Association of the NPAS3 gene and five other loci with response to the antipsychotic iloperidone identified in a whole genome association study. [2009]
A whole genome association study was performed in a phase 3 clinical trial conducted to evaluate a novel antipsychotic, iloperidone, administered to treat patients with schizophrenia. Genotypes of 407 patients were analyzed for 334,563 single nucleotide polymorphisms (SNPs)... These results provide new insight into response to iloperidone, developed with the ultimate goal of directing therapy to patients with the highest benefit-to-risk ratio.

more studies >>

Clinical Trials Related to Fanapt (Iloperidone)

Assessing the Effects of Fanapt� on Social Cognition in Schizophrenia [Terminated]
The study looks at whether treatment with iloperidone (Fanapt) is associated with improvements in social cognition in individuals who have been recently diagnosed with schizophrenia or schizoaffective disorder. Social cognition (the ability to understand your feelings and the feelings of others) is closely related to functional outcomes, including communication, empathy, and emotional recognition.

Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients [Completed]
This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be selected for assessment in Phase C. Phase C of this study is designed to define the dose-exposure relationship of the selected form and to provide information that will permit a comparison of the risk-benefit ratio of several doses of the study drug to enable optimal dose selection for later studies.

Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD) [Completed]
The purpose of the study is to determine whether Iloperidone is effective in the treatment of some symptoms in patients with PTSD, particularly difficulty falling or staying asleep, trauma dreams and daytime irritability or outbursts.

Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients [Active, not recruiting]
Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication

Switching to Iloperidone From Other Antipsychotics in Schizophrenia [Completed]
Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult subjects with schizophrenia who require a change in their current antipsychotic treatment of risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or safety/tolerability reasons.

more trials >>

Reports of Suspected Fanapt (Iloperidone) Side Effects

Dizziness (30)Weight Increased (20)Orthostatic Hypotension (19)Oedema Peripheral (16)Dyspnoea (15)Nausea (15)Priapism (15)Fall (13)Hypotension (13)Vomiting (12)more >>


Page last updated: 2014-11-30

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