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FDA Approves Vraylar for Maintenance Treatment of Schizophrenia

Medication previously approved for acute treatments

Cariprazine (Vraylar, Allergan PLC) has received FDA approval for the maintenance treatment of adults with schizophrenia. Cariprazine was previously approved for adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.

"Schizophrenia is one of the most challenging mental health disorders to manage—particularly due to the complexity of patient symptoms, varying response to treatment, and high rates of relapse," said Dr. Herbert Meltzer, Professor of Psychiatry and Behavioral Sciences at Northwestern Feinberg School of Medicine. "The goal of clinicians is to minimize relapses, which can cause significant personal distress, and can often have serious implications for a patient's health."

Without maintenance treatment, 60% to 70% of schizophrenia patients relapse within one year. Once a schizophrenia patient reaches the stable or maintenance phase of treatment, it is important for the physician to develop a long-term treatment management plan to minimize relapse risk, monitor for and reduce severity of side effects, and address residual symptoms where possible.

The efficacy of cariprazine in the maintenance treatment of schizophrenia was based on a multinational, double-blind, placebo-controlled, randomized withdrawal study in the prevention of relapse in adult patients with schizophrenia. 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 a relapse occurred. The primary endpoint was time to relapse during the randomized, double-blind phase. 

The study demonstrated that cariprazine significantly delayed the time to relapse compared with placebo (P = 0.0010). Relapse occurred in nearly twice as many placebo-treated patients (49.5%, 49 of 99) as cariprazine-treated patients (29.7%, 30 of 101). The safety results were consistent with the profile observed to date for cariprazine.

Schizophrenia is a chronic and disabling disorder that affects about 2.4 million American adults. It imposes significant burden on patients, their families, and society. Symptoms fall into three broad categories: positive symptoms (hallucinations, delusions, thought disorders, and movement disorders), negative symptoms (such as loss of motivation and social withdrawal), and cognitive symptoms (problems with executive functioning, focusing, and working memory).

Cariprazine is an oral, once daily atypical antipsychotic approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder, with a recommended dose range of 3 to 6 mg per day, and for the treatment of schizophrenia in adults, with a recommended dose range of 1.5 to 6 mg per day.

While the mechanism of action of cariprazine in schizophrenia and bipolar I disorder is unknown, its efficacy could be mediated through a combination of partial agonist activity at central dopamine D₂ and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.

Vraylar  carries a boxed warning noting that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Vraylar is not approved for treatment of patients with dementia-related psychosis.

Source: Allergan; November 13, 2017.

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