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 seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in 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. Loxapine succinate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[ b,f ] [1,4]oxazepine. It is present as the succinate salt.
Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine capsules in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
Media Articles Related to Loxapine
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 Loxapine
Rapid acute treatment of agitation in patients with bipolar I disorder: a
multicenter, randomized, placebo-controlled clinical trial with inhaled loxapine. 
of agitation in patients with bipolar I disorder... CONCLUSIONS: Inhaled loxapine provided a rapid, non-injection, well-tolerated
Off-label medication use. 
Prescribing medications for off-label uses is not illegal. Off-label prescribing
includes using medications for unapproved indications; using a drug outside of
the recommended dosage range or duration of use; using a drug in certain
unapproved patient populations, such as those defined by age, sex, or particular
clinical parameters; or intentionally using a medication in a patient who has a
Efficacy and safety of loxapine for inhalation in the treatment of agitation in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial. [2011.10]
CONCLUSIONS: Inhaled loxapine was generally safe and well tolerated and produced rapid improvement in agitated patients with psychotic disorders. Statistically significant differences in efficacy were found for the 10-mg dose compared with placebo, with results suggesting 5 mg may be effective. The delivery of loxapine by inhalation may provide a rapid, well-tolerated option for treating acute psychotic agitation that allows patients to avoid the aversive effects and loss of autonomy often associated with use of intramuscular medications. Further investigation of this new loxapine formulation is warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00369577. (c) Copyright 2011 Physicians Postgraduate Press, Inc.
Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. [2011.01]
CONCLUSIONS: Inhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.
Efficacy and safety of loxapine for inhalation in the treatment of agitation in
patients with schizophrenia: a randomized, double-blind, placebo-controlled
CONCLUSIONS: Inhaled loxapine was generally safe and well tolerated and produced
Clinical Trials Related to Loxapine
Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients [Terminated]
Neuroleptics are used since a long time in the management of severely agitated patients.
Loxapine is routinely used in our country, with, to our knowledge no severe adverse event
reported, in this indication.
However, recently, benzodiazepines have appeared interesting in agitated patients, with the
use of midazolam.
The aim of this study is to compare midazolam to loxapine in the treatment of severe
agitated patients admitted in the emergency department.
Staccato Loxapine Multidose PK [Completed]
QT/QTc Study of 2 Doses of ADASUVEļæ½ [Completed]
It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation
does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc
prolongation following repeat dosing is unknown. Therefore the current study will assess the
potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours
apart, in relation to placebo and an active control in healthy volunteers.
The study hypothesis H0: Placebo-subtracted max mean dQTc > 10 msec
Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning [Completed]
This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming
patients down in a situation of restlessness during mechanical ventilation weaning. This
drug is used for several years to quieten restless patients. Its purpose is to restore
spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical
Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting [Not yet recruiting]
Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted
in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety
profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when
self-administered outside of a hospital setting without the supervision of a healthcare
professional. The Study will aim to include approximately 500 patients who have been
previously treated with ADASUVEĀ® in the last 6 months prior to screening or recently treated
during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVEĀ®
responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about
30-34 centers. All patients will be followed up for a maximum of 6 months from baseline,
during which it is expected that a new episode of agitation will occur.
Reports of Suspected Loxapine Side Effects
Cardiogenic Shock (25),
Disseminated Intravascular Coagulation (17),
Neuroleptic Malignant Syndrome (16),
Extremity Necrosis (13),
Toxicity TO Various Agents (11),
Blood Pressure Decreased (7),
Multiple Drug Overdose (6),
Blood Glucose Increased (6), more >>
Page last updated: 2016-07-21