--- title: "Psych News Alert: FDA Approves Vraylar for Treatment of Schizophrenia and Bipolar Disorder" description: The Food and Drug Administration (FDA) last week approved Vraylar (cariprazine), a dopamine D2/D3 receptor partial agonist, as a treatme... image: https://alert.psychnews.org/hubfs/Imported_Blog_Media/FDA%20approved_180413006-Jun-24-2025-06-21-25-2525-PM.jpg --- 9/21/15 12:00 AM # FDA Approves Vraylar for Treatment of Schizophrenia and Bipolar Disorder ![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [ Psychiatric News Alert ](https://alert.psychnews.org/author/psychiatric-news-alert) Share: [facebook-f icon ](http://www.facebook.com/share.php?u=https://alert.psychnews.org/2015/09/fda-approves-vraylar-for-treatment-of.html) [linkedin-in icon ](http://www.linkedin.com/shareArticle?mini=true&url=https://alert.psychnews.org/2015/09/fda-approves-vraylar-for-treatment-of.html) [Twitter icon ](https://twitter.com/intent/tweet?url=https://alert.psychnews.org/2015/09/fda-approves-vraylar-for-treatment-of.html) [pinterest-p icon ](http://pinterest.com/pin/create/link/?url=https://alert.psychnews.org/2015/09/fda-approves-vraylar-for-treatment-of.html) [envelope icon ](mailto:?body=https://alert.psychnews.org/2015/09/fda-approves-vraylar-for-treatment-of.html) | ![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/FDA%20approved_180413006-Jun-24-2025-06-21-26-2261-PM.jpg?width=200&height=133&name=FDA%20approved_180413006-Jun-24-2025-06-21-26-2261-PM.jpg) | | | --- | --- | The Food and Drug Administration (FDA) last week [approved](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463103.htm) Vraylar (cariprazine), a dopamine D2/D3 receptor partial agonist, as a treatment for schizophrenia and bipolar disorder in adults. The approval was based on a set of six controlled clinical trials that included over 2,700 adults with bipolar disorder or schizophrenia. Vraylar was shown to reduce the symptoms of both disorders compared with placebo, and was fairly well tolerated, with the most commonly reported adverse reactions being extrapyramidal symptoms and restlessness (akathisia). Vraylar is one of the first FDA-approved antipsychotics that has demonstrated efficacy in alleviating negative symptoms of schizophrenia such as a lack of motivation or desire. It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient's individual needs,” Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Centre for Drug Evaluation and Research, said in an [FDA release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463103.htm). Gedeon Richter Plc. had previously submitted an approval request for this drug in 2013 that was turned down by the FDA, with the agency acknowledging the drug’s effectiveness but requesting more data, particularly information on optimal dosing for this oral, once-daily drug. According to a [release](http://www.allergan.com/news/news/thomson-reuters/allergan-and-gedeon-richter-plc-receive-fda-approv) by Gedeon Richter and Allergan, the recommended dose range for Vraylar for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder is 3 to 6 mg/day and 1.5 to 6 mg/day for the treatment of schizophrenia in adults. To learn more about cariprazine, see the *Psychiatric News* article “[As FDA Decision Nears, Cariprazine Collects More Proof of Efficacy](http://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2015.PP8b3). (Image: Hurst Photo/Shutterstock) [schizophrenia](https://alert.psychnews.org/tag/schizophrenia), [bipolar disorder](https://alert.psychnews.org/tag/bipolar-disorder), [FDA approval](https://alert.psychnews.org/tag/fda-approval), [antipsychotic medication](https://alert.psychnews.org/tag/antipsychotic-medication), [Food and Drug Administration](https://alert.psychnews.org/tag/food-and-drug-administration), [cariprazine](https://alert.psychnews.org/tag/cariprazine), [Vraylar](https://alert.psychnews.org/tag/vraylar) ## Related posts [![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/shutterstock_279641462-4.jpg?height=200&name=shutterstock_279641462-4.jpg) ](https://alert.psychnews.org/2015/11/cariprazine-found-to-be-effective-and.html) [bipolar depression](https://alert.psychnews.org/tag/bipolar-depression), [lurasidone](https://alert.psychnews.org/tag/lurasidone), [quetiapine](https://alert.psychnews.org/tag/quetiapine), [antipsychotics](https://alert.psychnews.org/tag/antipsychotics), [cariprazine](https://alert.psychnews.org/tag/cariprazine), [Vraylar](https://alert.psychnews.org/tag/vraylar) ## [Cariprazine Found to Be Effective and Well-Tolerated for Bipolar Depression](https://alert.psychnews.org/2015/11/cariprazine-found-to-be-effective-and.html) ![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [Psychiatric News Alert](https://alert.psychnews.org/author/psychiatric-news-alert) 11/6/15 12:00 AM An eight-week, randomized, controlled study published today in AJP in Advance has found that a 1.5... [ Read more ](https://alert.psychnews.org/2015/11/cariprazine-found-to-be-effective-and.html) [![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/FDA_NewLogo-Jun-24-2025-09-48-32-0835-PM.jpg?height=200&name=FDA_NewLogo-Jun-24-2025-09-48-32-0835-PM.jpg) ](https://alert.psychnews.org/2019/05/vraylar-now-approved-for-full-spectrum.html) [bipolar disorder](https://alert.psychnews.org/tag/bipolar-disorder), [bipolar depression](https://alert.psychnews.org/tag/bipolar-depression), [Allergan](https://alert.psychnews.org/tag/allergan), [cariprazine](https://alert.psychnews.org/tag/cariprazine), [Vraylar](https://alert.psychnews.org/tag/vraylar), [Stephen Stahl](https://alert.psychnews.org/tag/stephen-stahl), [depressive episode](https://alert.psychnews.org/tag/depressive-episode) ## [Vraylar Now Approved for Full Spectrum of Bipolar I Disorder Symptoms](https://alert.psychnews.org/2019/05/vraylar-now-approved-for-full-spectrum.html) ![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [Psychiatric News Alert](https://alert.psychnews.org/author/psychiatric-news-alert) 5/29/19 12:00 AM Yesterday the Food and Drug Administration (FDA) approved Vraylar (cariprazine) for the treatment... [ Read more ](https://alert.psychnews.org/2019/05/vraylar-now-approved-for-full-spectrum.html) [![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/elderly%20woman%20for%20AD_2644943-Jun-24-2025-05-18-21-3374-PM.jpg?height=200&name=elderly%20woman%20for%20AD_2644943-Jun-24-2025-05-18-21-3374-PM.jpg) ](https://alert.psychnews.org/2013/02/fda-provides-new-guidance-on-developing.html) [Alzheimer's disease](https://alert.psychnews.org/tag/alzheimers-disease), [FDA](https://alert.psychnews.org/tag/fda), [Food and Drug Administration](https://alert.psychnews.org/tag/food-and-drug-administration) ## [FDA Provides New Guidance on Developing Alzheimer's Drugs](https://alert.psychnews.org/2013/02/fda-provides-new-guidance-on-developing.html) ![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [Psychiatric News Alert](https://alert.psychnews.org/author/psychiatric-news-alert) 2/7/13 12:00 AM The Food and Drug Administration (FDA) today issued a proposal designed to assist pharmaceutical... 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