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 is a psychotropic agent that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles.
SAPHRIS is indicated for the following:
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].
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].
Media Articles Related to Saphris (Asenapine)
Clozapine Best Antipsychotic for Schizophrenia?
Source: Medscape Psychiatry & Mental Health Headlines [2016.07.21]
Real-world observational data suggest clozapine is the most effective and quetiapine is the least effective in schizophrenia.
Medscape Medical News
Evista Blunts Symptoms in Women With Schizophrenia
Source: MedPage Today OB/Gyn [2016.07.21]
(MedPage Today) -- No safety issues in small study, but thromboembolic risk remains concern
Clozapine shows better efficacy in children with schizophrenia than in adults
Source: Psychology / Psychiatry News From Medical News Today [2016.07.13]
Childhood-onset schizophrenia is a rare, severe, and difficult to treat form of the disease, but a new study suggests that children show a stronger response to clozapine than to other antipsychotic...
Analysis of genetic repeats suggests role for DNA instability in schizophrenia
Source: Schizophrenia News From Medical News Today [2016.06.24]
Variations in the number of DNA sequence repeats are known to exist between individuals.
European Commission approves TREVICTA (paliperidone palmitate 3-monthly injection), for schizophrenia
Source: Schizophrenia News From Medical News Today [2016.06.02]
Janssen has announced that the European Commission (EC) has approved the use of TREVICTA® (paliperidone palmitate, a 3-'monthly injection) for the maintenance treatment of schizophrenia.
Published Studies Related to Saphris (Asenapine)
Long-term effects of asenapine or olanzapine in patients with persistent negative
symptoms of schizophrenia: a pooled analysis. 
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. 
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. 
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.
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.
Reports of Suspected Saphris (Asenapine) Side Effects
Inappropriate Schedule of Drug Administration (141),
Swollen Tongue (56),
Weight Increased (47),
Hypoaesthesia Oral (37),
OFF Label USE (32),
Nausea (32), more >>
Page last updated: 2016-07-21