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FDA Accepts NDA Filing for Cariprazine for Treatment of Schizophrenia and Bipolar I Disorder

Drug is dopamine receptor partial agonist (Nov. 28)

A New Drug Application (NDA) has been submitted to the FDA for cariprazine (Forest Laboratories) for the treatment of both schizophrenia and manic or mixed episodes associated with bipolar I disorder. Cariprazine is a dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors. The drug has a low affinity at other receptor sites, such as 5-HT2C, muscarinic, and adrenergic receptors, which have been associated with adverse events.

The application for the treatment of schizophrenia includes results from three positive trials involving more than 1,700 patients — two fixed-dose studies with active controls and one fixed- and flexible-dose, placebo-controlled study. The primary efficacy endpoint in both trials was the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score.

The application for the acute treatment of manic or mixed episodes associated with bipolar I disorder includes results from three positive placebo-controlled trials involving more than 1,000 patients — two flexible-dose studies and one fixed- and flexible-dose study. Both trials used the change from baseline in the Young Mania Rating Scale (YMRS) total score as the primary efficacy endpoint.

In the schizophrenia and bipolar mania pivotal trials, cariprazine was generally well tolerated. The most commonly reported adverse reactions (= 5% and twice placebo) were akathisia, extrapyramidal disorder, dyspepsia, restlessness, tremor, fatigue, and vomiting.

Schizophrenia is a chronic and disabling disorder that affects more than 2 million American adults. The disorder imposes a significant burden on patients, their families, and society. The symptoms of schizophrenia 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).

Bipolar I disorder — also known as manic–depressive illness — is characterized by unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. It affects more than 5.7 million American adults. Patients experience "mood episodes," which manifest as either a manic episode (overexcited, extreme irritability, racing thoughts, and difficulties with sleep) or a depressive episode (extreme sadness, fatigue or hopelessness), or a combination of both.

Source: Forest Laboratories; September 28, 2012.

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