The recent FDA approval of the atypical or second-generation antipsychotic cariprazine (Vraylar) gives prescribers another option on the list of atypical antipsychotics that are used to treat acute manic or mixed episodes associated with bipolar I disorder and schizophrenia in adults.

Schizophrenia and bipolar disorder are considered to be chronic — and oftentimes disabling conditions if they are not diagnosed and treated immediately. In certain cases, it can take years before an individual is correctly and formally diagnosed with either one of these conditions.

With the addition of cariprazine, the availability of drugs to treat mental disorders such as bipolar disorder and schizophrenia continues to grow, and the level of mental health treatment continues to improve.

There are a handful of antipsychotics currently on the market, and the existence of cariprazine serve to add to the arsenal of agents that psychiatrists and other mental health professionals have to choose from. If a patient is intolerant to or refractory to the treatment or does not achieve the desired effect, another agent can be utilized.

The approval of cariprazine follows asenapine (Saphris), lurasidone (Latuda) and iloperidone (Fanapt), which have each been introduced after 2007, and after the approval of aripiprazole (Ablify) in 2002. Cariprazine is a dopamine D3 and D2 receptor partial agonist with a preferential binding to D3 receptors.

The research study that led to the approval of cariprazine was a controlled trial consisting of 2,791 adult participants with manic or mixed episodes of bipolar 1 and three six-week placebo controlled trials of adults with schizophrenia. The trials were able to demonstrate that those who were administered cariprazine showed improvement compared to placebo with the use of the Young Mania Rating Scale (YMRS) in total scores in patients with bipolar mania.

The side effects of cariprazine can include extrapyramidal symptoms such as tremor, slurred speech, involuntary muscle movements and restlessness, as well as drowsiness. It is important for pharmacists to counsel patients who are new starts on this medication so they are aware of how it will affect them. Patients should also be aware of potential long-term side effects that require monitoring, such as weight gain or metabolic changes.

The approval of cariprazine offers another treatment alternative for individuals suffering from these chronic mental illnesses, and ultimately allows for them to engage in activities of daily living.