FDA Approves Cariprazine for Use in Schizophrenia Maintenance

Published Online: Monday, November 13th, 2017
Officials with the FDA have approved the supplemental new drug application (sNDA) for cariprazine (Vraylar, Allergan) for use in adults for the maintenance treatment of schizophrenia, according to an Allergan statement. 

Cariprazine was previously approved for use in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.

Cariprazine is a once-daily atypical antipsychotic, with a recommended dose range of 3 to 6 mg/day for patients with bipolar I disorder, and a recommended dose range of 1.5 to 6 mg/day for adults with schizophrenia.

The sNDA approval was based on a 72-week study that demonstrated the prevention of relapse in adult patients with schizophrenia who used cariprazine. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6, or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized either to continue their cariprazine dose or be switched to placebo for up to 72 weeks or until relapse.

According to the findings, cariprazine significantly delayed the time to relapse, compared with placebo, with relapse occurring in nearly twice as many placebo-treated patients as those treated with cariprazine. 

The safety results were consistent with the profile observed to-date for cariprazine.  

This article originally appeared on Pharmacy Times. 


Allergan receives FDA approval for use of Vraylar (cariprazine) in the maintenance treatment of schizophrenia [news release]. Dublin, Ireland; November 13, 2017. allergan.com/news/news/thomson-reuters/allergan-receives-fda-approval-for-use-of-vraylar. Accessed November 13, 2017.

Current Issue

The Educated Patient

Kristen Marjama, DNP, FNP-BC
It is that time of year again, when health care providers see an increase in patient volume because no one has time to be sick.
Sara Marlow, MSN, RN, PHN, FNP-C
Sunburn is still a major health issue that can be prevented.
Kristen Marjama, DNP, FNP-BC
The National Health Interview Survey in 2014 estimated that 17.7 million adults and 6.3 million children had asthma.
Mary McCormack, MSN, APNC, MPH
The World Gastroenterology Organization describes the prevalence of celiac disease as a “statistical iceberg” in today’s health climate.
$vacMongoViewPlus$ $vAR$
Contemporary Clinic
MJH Associates
American Journal of Managed Care
MD Magazine
Pharmacy Times
Specialty Pharmacy Times
Targeted Oncology
About Us
Contact Us
Terms & Conditions
Pharmacy Healthcare & Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-257-0701

Copyright Contemporary Clinic 2017
Pharmacy Healthcare & Communications, LLC. All Rights Reserved.