Risvan FDA Approval History
Last updated by Judith Stewart, BPharm on April 9, 2024.
FDA Approved: Yes (First approved March 29, 2024)
Brand name: Risvan
Generic name: risperidone
Dosage form: for Extended-Release Injectable Suspension
Company: Laboratorios Farmacéuticos Rovi, S.A.
Treatment for: Schizophrenia
Risvan (risperidone) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults.
- Schizophrenia is a chronic, serious and disabling mental disorder characterized by a mixture of symptoms including delusional ideas, hallucinations, disorganized language and behaviour, affective flattening, speech poverty, and abulia.
- Risperidone is thought to work in the treatment of schizophrenia through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism.
- Risperidone is a well established treatment for schizophrenia first approved in an oral tablet formulation under the brand name Risperdal in 1993.
- Risvan is an extended-release injectable suspension formulation of risperidone administered by intramuscular injection once monthly. Risvan is designed to provide immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone.
- FDA approval of Risvan was based on positive results of the pivotal PRISMA-3 study. Both doses of Risvan (75 mg and 100 mg once a month) achieved the primary efficacy endpoint (significant improvement in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) total score compared with placebo) and the secondary efficacy endpoint (improved mean changes in Clinical Global Impressions-Severity (CGI-S) score compared with placebo).
- The Risvan product label carries a Boxed Warning for increased mortality in elderly patients with dementia-related psychosis.
- Warnings and precautions associated with Risvan include neuroleptic malignant syndrome; tardive dyskinesia; hyperprolactinemia; orthostatic hypotension and syncope; leukopenia, neutropenia, and agranulocytosis; potential for cognitive and motor impairment; seizures; and priapism.
- The most frequently reported adverse reactions in clinical trials (≥ 5% and twice placebo) include hyperprolactinaemia, increased blood prolactin, akathisia, headache, sedation (including somnolence), increased weight, injection site pain, and increased alanine aminotransferase.
Development timeline for Risvan
| Date | Article |
|---|---|
| Apr 2, 2024 | Approval FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia |
Further information
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