New FDA Approval: RISVAN® (risperidone)
The Food and Drug Administration (FDA) has approved Risvan® (risperidone for extended-release injectable suspension) for the treatment of adults with schizophrenia.
Read InpharmD's summary below:
| Drug Name |
RISVAN® |
| Active Ingredient |
risperidone |
| Date of Approval |
3/29/24 |
| Manufacturer |
Laboratorios Farmaceuticos ROVI |
| Approval Pathways and Indications |
Approval: NDA
Indication: RISVAN® is an atypical antipsychotic indicated for the treatment of schizophrenia in adults. |
| Therapeutic Class |
Antimanic Agent; Second Generation (Atypical) Antipsychotic |
| Formulation |
Extended-Release Injectable Suspension |
| MoA |
The mechanism of action of risperidone, in schizophrenia, is unclear. The drug’s therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major metabolite, 9-hydroxyrisperidone (paliperidone). Antagonism at receptors other than D2 and 5HT2 may explain some of the other effects of risperidone. |
| Dosing and Administration |
For extended-release injectable suspension: 75 mg and 100 mg risperidone.
• Administer by intramuscular injection in the gluteal or deltoid muscle by a healthcare professional. Do not administer by any other route.
• Establish tolerability with oral risperidone prior to initiating treatment with RISVAN®.
• RISVAN® may be initiated at a dosage of 75 mg or 100 mg once monthly. Do not administer more than one dose per month.
• Supplementation with oral risperidone is not recommended.
• Patients who are on stable oral risperidone doses lower than 3 mg per day or higher than 4 mg per day may not be candidates for RISVAN®.
• Renal or Hepatic Impairment: Titrate with oral risperidone to at least 3 mg prior to initiating treatment with RISVAN®. Following oral titration, the recommended dosage of RISVAN® is 75 mg once monthly. |
| Place in Therapy |
Administered by HCP |
| Expected Market Launch Date |
RISVAN® is a prolonged-release injectable antipsychotic developed for the treatment of schizophrenia in adults, which, as of the first injection, provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone.
Prior to initiating treatment with RISVAN®, tolerability with oral risperidone should be established.
Extended-release/long-acting anti-psychotic injections may reduce the risk of schizophrenia relapse. |
| New Molecular Entity (NME) or Existing Formulation |
Anticipated availability is currently unknown. |
| Expected Cost |
Existing Formulation |
| Product Discontinuation |
Expected cost is unavailable. |
| |
N/A |
| |
The approval was based on data from the 12-week randomized, double-blind, placebo-controlled phase 3 PRISMA-3 study (ClinicalTrials.gov Identifier: NCT03160521). The study evaluated the efficacy and safety of IM injections of RISVAN® in adults with acute exacerbation of schizophrenia.
Study participants were randomly assigned 1:1:1 to receive RISVAN® 75mg, 100mg, or placebo IM every 4 weeks for a total of 3 doses. The primary efficacy outcome was the mean change in Positive and Negative Syndrome Scale (PANSS) total score day 1 (baseline) to day 85 (or the last post baseline assessment).
Results showed the trial met its primary endpoint demonstrating a statistically significant improvement in PANSS total score at day 85 with RISVAN® 75mg (mean adjusted difference, -13.0 [95% CI, -17.3, -8.8]; P <0.0001) and Risvan 100mg (mean adjusted difference, -13.3 [95% CI, -17.6, -8.9]; P <0.0001) compared with placebo. |
| |
1. Brian Park, P. (2024, April 4). Long-acting RISVAN approved for schizophrenia treatment. MPR. https://www.empr.com/home/news/long-acting-risvan-approved-for-schizophrenia-treatment/
2. Zavala. (2024, April 1). Rovi receives the FDA’s approval of Risvan® as a treatment for schizophrenia. zavala. https://www.rovi.es/en/content/rovi-receives-fdas-approval-risvanr-treatment-schizophrenia#xd_co_f=ZWYwYzVhZGItMTFiOC00M2Q5LWI1NmItZjg5ZjgwNTJhODAz~ |
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