FDA approves Vraylar (Cariprazine) extended indications jointly developed by ElJian and Gedeon Richter
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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today, Allergan and Gedeon Richter announcedThe FDA(http://approved its co-development of Vraylar (Cariprazine, Calipraquin) extended indications to treat depressive episodes associated with type I bipolar disorder (biopolar disorder) in adultsas an oral, dailyof atypical antipsychoticdrug (http://, Vraylar has previously been approved for the treatment of adult schizophrenia, as well as acute treatment of manic or adult bipolar disorder associated with bipolar disorderVraylar may be a drug-effect by partially activating the central nervous system's dopamine D and serotonin 5-HT1A receptors, as well as inhibiting serotonin 5-HT2A receptorsVraylar is currently conducting phase 3 clinicaltrial(http://for severe depressionThis approval for extended indications is based on the results of three clinical trials of RGH-MD-53, RGH-MD-54 and RGH-MD-56Three trials showed that Vraylar improved the patient's depressive symptoms significantly after six weeks of treatment compared to placebo (using the Montgomery-Asberg Depression Scale-MADRS)
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