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].
|
|
NEWS HIGHLIGHTSMedia Articles Related to Saphris (Asenapine)
Schizophrenia 'Guideline of Guidelines' Released
Source: Medscape Psychiatry & Mental Health Headlines [2013.05.16]
New "meta-guidelines" combining recommendations from several expert organizations on the management and treatment of schizophrenia have been released.
Medscape Medical News
Model Cell System Offers Insights Into Epilepsy, Schizophrenia, Other Neuropsych Disorders
Source: Autism News From Medical News Today [2013.05.06]
Medical researchers have manipulated human stem cells into producing types of brain cells known to play important roles in neurodevelopmental disorders such as epilepsy, schizophrenia and autism...
Neurons In The Nose Could Be The Key To Early, Fast, And Accurate Diagnosis Of Schizophrenia
Source: Schizophrenia News From Medical News Today [2013.05.01]
A debilitating mental illness, schizophrenia can be difficult to diagnose. Because physiological evidence confirming the disease can only be gathered from the brain during an autopsy, mental health professionals have had to rely on a battery of psychological evaluations to diagnose their patients. Now, Dr. Noam Shomron and Prof...
Schizophrenia May Be Diagnosed By Testing Nerve Cells From The Nose
Source: Schizophrenia News From Medical News Today [2013.05.01]
Collecting neurons from the nose could be a fast way to test for schizophrenia, a debilitating mental illness that is often difficult to diagnose. This was the finding of a new study led by researchers from Tel Aviv University (TAU) in Israel...
The Dual Role Of Testosterone In Schizophrenia
Source: Endocrinology News From Medical News Today [2013.04.30]
Researchers from Neuroscience Research Australia (NeuRA) have presented new results about the role of testosterone in schizophrenia at the International Congress on Schizophrenia Research being held in Orlando, Florida. They have found that, on the one hand, testosterone could be the trigger for the onset of schizophrenia...
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
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.
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: 2013-05-16
|
