FDA Approves Cariprazine for Depression in Bipolar I Disorder

FDA Approves Cariprazine for Depression in Bipolar I Disorder

Posted: June 20, 2019
FDA Approves Cariprazine for Depression in Bipolar I Disorder

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Receiving FDA approval for use in treating depression in bipolar I disorder following three pivotal clinical trials, cariprazine (Vraylar) can now be used for treating both phases of the disorder ie. depression and mania.


On May 28th, the U.S. Food and Drug Administration (FDA) approved cariprazine for the treatment of depressive episodes in adults with bipolar I disorder. Sold under the brand name Vraylar, the medicine, which is given orally, previously had been approved to treat manic or mixed episodes in adult bipolar I patients. It had also been approved previously for use in schizophrenia.

The dose recommended by the FDA for bipolar I depression ranges from 1.5 mg to 3mg per day. In the acute treatment of manic or mixed bipolar episodes, the suggested dosages are higher, 3mg to 6 mg per day.

People with bipolar I disorder experience a range of depressive and manic symptoms over the course of their illness, and sometimes both at once (so-called mixed episodes). This can complicate both diagnosis and treatment. With its approval in bipolar I depression, cariprazine is now approved for treatment of both manic and depressive episodes in bipolar I disorder.

Cariprazine is thought to interact with specific receptors for dopamine and serotonin in the brain. The FDA approval was based on the results of three clinical trials, in which cariprazine demonstrated greater benefit than placebo after 6 weeks.

Dr. Lakshmi N. Yatham, M.B.B.S., F.R.C.P.C., a 2018 Colvin Prizewinner, 2003 and 1999 BBRF Independent Investigator and 1996 BBRF Young Investigator, and Willie Earley, M.D., of the pharmaceutical firm Allergan, which makes cariprazine, were the senior and lead authors of two of these studies. Reporting the results of the more recent study in The American Journal of Psychiatry this past March, the team paid close attention to side-effects. Significant weight gain, a potential issue in second-generation antipsychotic medicines, was not observed, although the trial was of relatively short duration. The medicine was not associated with mood destabilization or “manic switching,” and showed “improved tolerability” relative to when it is used (at a higher dosage) to treat mania.

Bipolar I disorder, affecting about 2 percent of the population, is associated with functional disability and elevated suicide risk. Most patients first seek help when they experience a depressive episode, and while depressive episodes dominate the illness over the long-term, bipolar I disorder patients have at least one episode of mania (characterized by a high state of arousal, highly elevated mood similar to euphoria, and a propensity for risky behavior, among other features). It is distinguished from bipolar II disorder in that patients with the latter do not experience full-blown mania but rather hypomania, a less intense although no less serious state.

While there are several effective and approved medicines for treating bipolar I mania, “there are fewer evidence-based approved treatment options for bipolar I depression,” as Dr. Yatham and colleagues pointed out when reporting their study.