ADASUVE
Loxapine capsules are indicated for the treatment of schizophrenia. Its efficacy was established in clinical trials involving acutely ill subjects across both newly hospitalized and chronically hospitalized populations. (Note: If the intended drug is the brand ADASUVE, the indication is specifically for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults).
How ADASUVE Works
Loxapine is a dibenzoxazepine antipsychotic. Although its exact mechanism of action is not fully understood, it is thought to mediate its antipsychotic effects through high-affinity antagonism of dopamine D2 receptors and serotonin 5-HT2A receptors. It also demonstrates affinity for noradrenergic, histaminergic, and cholinergic receptors, which contributes to its side effect profile.
Details
- Status
- Prescription
- First Approved
- 2012-12-21
- Routes
- INHALATION
- Dosage Forms
- POWDER
ADASUVE Approval History
What ADASUVE Treats
1 indicationsADASUVE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
ADASUVE Boxed Warning
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 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 contro...
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 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 is not approved for the treatment of patients with dementia-related psychosis ( see WARNINGS ).
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADASUVE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
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 seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients takin...
ADASUVE Patents & Exclusivity
Patents (1 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.