PERPHENAZINE
Perphenazine tablets, USP are indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine tablets, USP have not been shown effective for the management of behavioral complications in patients with mental retardation.
Details
- Status
- Prescription
- First Approved
- 1987-09-10
- Routes
- ORAL
- Dosage Forms
- TABLET, CONCENTRATE
Companies
PERPHENAZINE Approval History
What PERPHENAZINE Treats
12 FDA approvalsOriginally approved for its first indication in 1987 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (Sep 1987)
- • Approved indication (Dec 1988)
- • Approved indication (Dec 1998)Label Letter
- • Approved indication (May 2001)Letter
- • Approved indication (Dec 2015)
- • Approved indication (Oct 2016)Letter
- • Approved indication (Apr 2017)
- • Approved indication (Mar 2019)
- • Approved indication (Apr 2020)
- • Approved indication (May 2022)
- • Approved indication (May 2024)
- • Approved indication (Mar 2025)
PERPHENAZINE 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. Perphenazine tablets, USP are not approved for the treatment of patients with dementia-related psychosis ( see WARNINGS ).
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04606264 | STUDY19030022 | Ph 3 | completed | Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data |
| NCT02431702 DREaM results posted | CR106193 R092670SCH3013 | Ph 3 | completed | A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform |
| NCT02199743 results posted | STU 032012-053 | Ph 4 | completed | Lurasidone Effects on Tissue Glutamate in Schizophrenia |
| NCT02307396 | 1723/1-1 2013-000338-37, DO 1723/1-1 | Ph 4 | completed | Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01157351 results posted | CR015625 R092670SCH3006 | Ph 4 | completed | 15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated |
| NCT01193166 | CR017110 R092670SCH4003 | Ph 4 | withdrawn | Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital |
| NCT00802100 COATS results posted | N01 MH090001-02 N01MH90001, N01MH090001 | Ph 4 | completed | Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia |
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.
PERPHENAZINE FDA Label Details
Indications & Usage
FDA Label (PDF)Perphenazine tablets, USP are indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine tablets, USP have not been shown effective for the management of behavioral complications in patients with mental retardation.
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...
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Full clinical data, patents, trials, and competitive landscape for perphenazine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.