On Thursday, the U.S. Food and Drug Administration (FDA) approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.
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The efficacy of Vraylar in treating bipolar disorder was shown in three three-week clinical trials of 1,037 participants.
United States clearance was based on a package of clinical data garnered from more than 2,700 adults, showing that Vraylar improved symptoms of both schizophrenia and bipolar disorder with an acceptable tolerability profile.
Treatment with Vraylar showed improvement vs. placebo as measured by Young Mania Rating Scale (YMRS) total scores in patients with bipolar mania and by Positive and Negative Syndrome Scale (PANSS) total scores in patients with schizophrenia.
“Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities”, said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in an FDA press release.
Like other antipsychotics, cariprazine will come with a boxed warning about increased risk of death in older people with dementia-related psychosis.
The drug company Allergan has just announced that the FDA has approved their new formulation for the treatment of schizophrenia and bi-polar disorder. For bipolar patients, common side effects were, aside from the extrapyramidal symptoms, indigestion, agitation and drowsiness.
Cariprazine is a partial agonist of the dopamine D3 and D2 and serotonin 5-HT1A receptors.
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Gedeon Richter Nyrt., hit by eroding sales in some of its European markets, headed for the biggest gain in five months after U.S. authorities granted approval for an anti-psychotic drug developed jointly with Allergan Plc. Currently, Vraylar is being studied for the treatment of bipolar depression and as an adjunctive treatment for major depressive disorder in adults.
