Erzofri FDA Approval History
Last updated by Judith Stewart, BPharm on July 31, 2024.
FDA Approved: Yes (First approved July 26, 2024)
Brand name: Erzofri
Generic name: paliperidone palmitate
Dosage form: Extended-Release Injectable Suspension
Company: Luye Pharma Group
Treatment for: Schizophrenia, Schizoaffective Disorder
Erzofri (paliperidone palmitate) is an atypical antipsychotic used for the treatment of schizophrenia and schizoaffective disorder.
- Both schizophrenia and schizoaffective disorder are severe, chronic, psychiatric disorders. Schizophrenia is characterised by hallucinations, delusions, and disorganized thinking and behavior. Schizoaffective disorder is a condition that includes schizophrenia symptoms in addition to mood disorder symptoms such as depression, mania, and hypomania.
- Erzofri contains the atypical antipsychotic paliperidone palmitate which is hydrolyzed to paliperidone (the major active metabolite of risperidone) after injection. Paliperidone is thought to work in the treatment of schizophrenia through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism.
- Paliperidone was first FDA approved in extended-release tablet form under the brand name Invega for the treatment of schizophrenia in 2006, and paliperidone palmitate extended-release injectable suspension was approved under the brand name Invega Sustenna for the treatment of schizophrenia in 2009.
- Erzofri was approved by the FDA as a new drug under the 505(b) (2) pathway based on on the results of a study (NCT04922593) that demonstrated Erzofri was bioequivalent to Invega Sustenna at steady state after multiple injections. Invega Sustenna requires dosing on Day 1 and Day 8, followed by once monthly maintenance doses. The initial dosing for Erzofri is optimized by omitting the dose on Day 8, resulting in a comparable total drug exposure when compared to Invega Sustenna .
- Erzofri is administered by intramuscular injection once monthly after one initial dose.
- Erzofri comes with a Boxed Warning for an increased risk of death in elderly patients with dementia-related psychosis. Warnings and precautions include an increased incidence of cerebrovascular adverse reactions in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; QT prolongation; tardive dyskinesia; metabolic changes, orthostatic hypotension and syncope; leukopenia, neutropenia, and agranulocytosis; hyperprolactinemia; the potential for cognitive and motor impairment; and seizures.
- Common adverse reactions include injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.
Development timeline for Erzofri
| Date | Article |
|---|---|
| Jul 28, 2024 | Approval FDA Approves Erzofri (paliperidone palmitate) for the Treatment of Schizophrenia and Schizoaffective Disorder |
Further information
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