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October 30, 2020 04:00am
By Jennifer Gershman, PharmD, CPh
Officials with the FDA have approved the supplemental new drug application (sNDA) for cariprazine (Vraylar, Allergan) for use in adults for the maintenance treatment of schizophrenia.
Officials with the FDA have approved the supplemental new drug application (sNDA) for cariprazine (Vraylar, Allergan) for use in adults for the maintenance treatment of schizophrenia, according to an Allergan statement.
Cariprazine was previously approved for use in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.
Cariprazine is a once-daily atypical antipsychotic, with a recommended dose range of 3 to 6 mg/day for patients with bipolar I disorder, and a recommended dose range of 1.5 to 6 mg/day for adults with schizophrenia.
The sNDA approval was based on a 72-week study that demonstrated the prevention of relapse in adult patients with schizophrenia who used cariprazine. 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 relapse.
According to the findings, cariprazine significantly delayed the time to relapse, compared with placebo, with relapse occurring in nearly twice as many placebo-treated patients as those treated with cariprazine.
The safety results were consistent with the profile observed to-date for cariprazine.
Allergan receives FDA approval for use of Vraylar (cariprazine) in the maintenance treatment of schizophrenia [news release]. Dublin, Ireland; November 13, 2017.allergan.com/news/news/thomson-reuters/allergan-receives-fda-approval-for-use-of-vraylar. Accessed November 13, 2017.