Expanded Dosing Interval for Aristada Under FDA Review
Alkermes announced that it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for a two-month dosing interval of Aristada (aripiprazole lauroxil), providing a third dosing option for the treatment of schizophrenia.
The sNDA for a potential expanded dosing interval is supported by positive data from a recent randomized, open-label pharmacokinetic (PK) and safety study comparing the investigational two-month interval to the FDA-approved once-monthly and once every 6 weeks intervals. Patients were randomized to receive either Aristada 441mg once monthly, 882mg every 6 weeks or 1,064mg every 2 months. The 1,064mg dose was found to achieve therapeutically relevant plasma concentrations of aripiprazole with a PK profile that supports dosing once every two months.
Aristada is an extended-release, injectable atypical antipsychotic.
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