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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)

Adjunctive ECT Effective for Drug-Resistant Schizophrenia
Source: Medscape Psychiatry & Mental Health Headlines [2014.09.12]
Augmenting clozapine-resistant schizophrenia with electroconvulsive therapy is a safe and effective treatment option.
Medscape Medical News

Is the pattern of brain folding a "fingerprint" for schizophrenia?
Source: Biology / Biochemistry News From Medical News Today [2014.09.12]
Anyone who has seen pictures or models of the human brain is aware that the outside layer, or cortex, of the brain is folded in an intricate pattern of "hills", called gyri, and "valleys", called...

Is OCD a risk factor for schizophrenia?
Source: Mental Health News From Medical News Today [2014.09.04]
People with a prior OCD diagnosis and those whose parents have the condition may be at higher risk of developing schizophrenia, according to the results of a Danish study.

People With OCD May Have Higher Odds for Schizophrenia: Study
Source: MedicineNet Schizophrenia Specialty [2014.09.04]
Title: People With OCD May Have Higher Odds for Schizophrenia: Study
Category: Health News
Created: 9/3/2014 4:35:00 PM
Last Editorial Review: 9/4/2014 12:00:00 AM

Motivation deficits in schizophrenia driven by difficulty assessing effort
Source: Schizophrenia News From Medical News Today [2014.08.25]
Individuals with schizophrenia often have trouble engaging in daily tasks or setting goals for themselves, and a new study from San Francisco State University suggests the reason might be their...

more news >>

Published Studies Related to Saphris (Asenapine)

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.

A double-blind, randomized study comparing the efficacy and safety of sertindole and risperidone in patients with treatment-resistant schizophrenia. [2011]
CONCLUSIONS: Sertindole and risperidone are effective and well-tolerated in

more studies >>

Clinical Trials Related to Saphris (Asenapine)

Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896 AM1) [Recruiting]
This study is designed to evaluate whether asenapine, which is a US FDA-approved acute treatment for 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 Positive and Negative Syndrome Scale (PANSS) total score at Day 56.

Once-Daily Asenapine for Schizophrenia [Not yet recruiting]
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

Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125) [Recruiting]
This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in participants with schizophrenia. The first six weeks of the study will be double-blind and the remainder of the study will be open label. Participants in this study consist of participants who have completed the preceding short-term study (P06124), who meet the inclusion criteria and wish to continue receiving study drug, and whom the investigators have deemed eligible for study participation. Participants who were on placebo bid in core trial P06124 will get placebo for the first 2 weeks then 5 mg asenapine for the next 4 weeks of double blind treatment, and will be re-randomized after week 6 to asenapine 5 mg bid or asenapine 10 mg bid. Participants who were on asenapine 5 mg bid in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg twice daily (bid) or asenapine 10 mg bid Participants who were on asenapine 10 mg twice daily (bid) in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg bid or asenapine 10 mg bid

Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder {P06107 Has an Extension (P05898; NCT01349907}(P06107 AM3) [Recruiting]
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, patients eligible for participation will be randomized to receive one out of three fixed dose levels of asenapine, or placebo. 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 the Young Mania Rating Scale (Y-MRS) and safety is evaluated using the recordings of adverse events, routine blood panels, physical examinations (including vital signs), and electrocardiograms. Patients 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 patients within 30 days following treatment discontinuation.

Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692AM2) [Recruiting]
Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.

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: 2014-09-12

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