Allergan and Gedeon Richter announces the US FDA's approval for VRAYLAR capsules for the acute treatment of bipolar I disorder and schizophrenia.
M2 PHARMA-September 18, 2015-Allergan and Gedeon Richter announces the US FDA's approval for VRAYLAR capsules for the acute treatment of bipolar I disorder and schizophrenia
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Pharmaceutical company Allergan (NYSE:AGN) and Gedeon Richter Thursday jointly announced the receipt of US Food and Drug Administration (FDA) approval for VRAYLAR (cariprazine) capsules for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.
The companies added that VRAYLAR 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/day and for treating schizophrenia in adults, with a recommended dose range of 1.5 to 6 mg/day.
VRAYLAR's safety and efficacy was studied by the companies in a clinical trial programme in these 2,700 patients. The US FDA approval is based on the results of three three week controlled trials in adults with manic or mixed episodes of bipolar I disorder and three-six week placebo-controlled trials in adults with schizophrenia.
In these clinical trials, VRAYLAR demonstrated improvement compared to 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, according to the companies.
Bipolar I disorder and schizophrenia are chronic and disabling mental health disorders. Bipolar I disorder, also known as manic-depressive illness, is a disorder of the brain that is characterized by fluctuations in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Schizophrenia is characterized by delusions, hallucinations, disorganized speech and behavior, and other symptoms that cause social or occupational dysfunction.
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|Date:||Sep 18, 2015|
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