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Saphris (Asenapine Maleate) - 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 the drug-treated patients of between 1.6 to 1.7 times that seen 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. SAPHRIS® (asenapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions].

 

SAPHRIS SUMMARY

SAPHRIS is a psychotropic agent that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles.

SAPHRIS is indicated for the following:

Schizophrenia

SAPHRIS is indicated for the acute treatment of schizophrenia in adults [see Clinical Studies]. The physician who elects to use SAPHRIS for extended periods in schizophrenia should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient [see Dosage and Administration].

Bipolar Disorder

SAPHRIS is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults [see Clinical Studies]. If SAPHRIS is used for extended periods in bipolar disorder, the physician should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient [see Dosage and Administration].


See all Saphris indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Saphris (Asenapine)

Genetic study provides first-ever insight into biological origin of schizophrenia
Source: Genetics News From Medical News Today [2016.01.28]
A landmark study, based on genetic analysis of nearly 65,000 people, has revealed that a person's risk of schizophrenia is increased if they inherit specific variants in a gene related to "synaptic...

Scientists Uncover Clues to Origins of Schizophrenia
Source: MedicineNet Schizophrenia Specialty [2016.01.28]
Title: Scientists Uncover Clues to Origins of Schizophrenia
Category: Health News
Created: 1/27/2016 12:00:00 AM
Last Editorial Review: 1/28/2016 12:00:00 AM

Monoclonal antibody holds promise of reducing learning, memory problems in schizophrenia
Source: Schizophrenia News From Medical News Today [2016.01.26]
Chronic learning and memory problems that plague patients with schizophrenia may have a worthy foe in a monoclonal antibody that also holds promise in the fight against cancer and is already used...

Computer modeling provides insight into cellular-level effects of schizophrenia risk genes
Source: IT / Internet / E-mail News From Medical News Today [2016.01.22]
Numerous genetic variants associated with risk for schizophrenia have been identified. However, little is known about how these genes have their effects in the brain.

Computer modeling provides insight into cellular-level effects of schizophrenia risk genes
Source: Schizophrenia News From Medical News Today [2016.01.21]
Numerous genetic variants associated with risk for schizophrenia have been identified. However, little is known about how these genes have their effects in the brain.

more news >>

Published Studies Related to Saphris (Asenapine)

Long-term effects of asenapine or olanzapine in patients with persistent negative symptoms of schizophrenia: a pooled analysis. [2013]
prompted a pooled analysis of the treatment effects of both drugs... CONCLUSION: In this pooled analysis, ASE and OLA did not differ significantly

Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. [2012]
In a 12-week randomized, placebo-controlled study evaluating the efficacy and safety of adjunctive asenapine, bipolar I disorder patients experiencing manic or mixed episodes despite pretreatment with lithium or valproate monotherapy were treated with flexible-dose, twice-daily asenapine 5 or 10 mg (n = 158) or placebo (n = 166)...

A randomized placebo-controlled trial of asenapine for the prevention of relapse of schizophrenia after long-term treatment. [2011.03]
CONCLUSIONS: Long-term treatment with asenapine was more effective than placebo in preventing relapse of schizophrenia and appeared to be safe and well tolerated. TRIAL REGISTRATION: clinicaltrials.gov Identifier NCT00150176. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

Comparison of QTc data analysis methods recommended by the ICH E14 guidance and exposure-response analysis: case study of a thorough QT study of asenapine. [2011.01]
An assessment of the effects of asenapine on QTc interval in patients with schizophrenia revealed a discrepancy between the results obtained by two different methods: an intersection-union test (IUT) (as recommended in the International Conference on Harmonisation E14 guidance) and an exposure-response (E-R) analysis.

Role of sublingual asenapine in treatment of schizophrenia. [2011]
Asenapine tablets are a new option for the treatment of schizophrenia... Obstacles to the use of asenapine are the recommendations for twice-daily dosing and the need to avoid food or liquids for 10 minutes after administration, although the bioavailability is only minimally reduced if food or liquids are avoided for only two minutes.

more studies >>

Clinical Trials Related to Saphris (Asenapine)

Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896) [Completed]
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also effective in adolescents with schizophrenia. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 2. 5 mg or 5 mg twice daily [BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each participant at various times to assess the efficacy and safety of the study treatment. The primary objective of the trial is to demonstrate significant superiority of at least one asenapine dose to placebo, as measured by the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.

Once-Daily Asenapine for Schizophrenia [Completed]
The investigators propose to explore: 1. the acceptance by patients of once versus twice daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing with asenapine, and 3. the changes in psychopathology associated with these two dosing strategies, in 30 patients with schizophrenia or schizoaffective disorder. The investigators hypothesize that patient and staff acceptance will be better with once daily dosing and that improvements in psychopathology will be similar across once daily and twice daily dosing

Bio-equivalence Study Between SAPHRIS and Asenapine [Completed]
This is a Multiple-dose, steady state, three-way reference-replicated crossover study. The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine 10mg sublingual tablets.

Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691) [Completed]
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily [BID]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale [YMRS]) at Day 21 of the trial.

Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107) [Completed]
Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 10 and 17 years old, who are either hospitalized or non-hospitalized. In this 3-weeks, double-blind, parallel design trial, eligible participants will be randomized to receive one out of three fixed dose levels of asenapine, or placebo. The study primary hypothesis is that at least one asenapine dose is superior to placebo as measured by the change from baseline to Day 21 in Young Mania Rating Scale (Y-MRS) total score. Trial medication and placebo are provided as identical-looking sublingual tablets; concurrent use of psychotropics is prohibited, except use of short-acting benzodiazepines and psychostimulants approved for the treatment of attention deficit hyperactivity disorder (ADHD). Main treatment effect is measured using Y-MRS and safety is evaluated using the recordings of adverse events, routine blood panels, physical examinations (including vital signs), and electrocardiograms. Participants who complete the double blind trial may be offered to continue (open-label) treatment with asenapine for an extended period of time. Follow-up information on safety parameters will be collected in all participants within 30 days following treatment discontinuation.

more trials >>

Reports of Suspected Saphris (Asenapine) Side Effects

Inappropriate Schedule of Drug Administration (141)Underdose (92)Swollen Tongue (56)Weight Increased (47)Dyspnoea (40)Dizziness (38)Hypoaesthesia Oral (37)Rash (35)OFF Label USE (32)Nausea (32)more >>


Page last updated: 2016-01-28

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