Aristada Under Investigation for 2-Month Dosing Interval in PK Study
Alkermes announced positive top-line results from its Phase 1 pharmacokinetics (PK) trial of Aristada (aripiprazole lauroxil extended-release injectable suspension) for the treatment of schizophrenia.
The randomized, open-label trial evaluated the pharmacokinetics, safety, and tolerability of Aristada given at the investigational 2-month dosing interval as well as the approved dosing intervals of once monthly and once every 6 weeks.
A total of 140 patients with stable schizophrenia were randomized to receive either 441mg Aristada once monthly, 882mg Aristada every 6 weeks or 1064mg Aristada every 2 months, for a total of 8 months. Study results showed that the 1064mg dose of Aristada achieved therapeutically relevant plasma concentrations of aripiprazole with a PK profile that supports dosing once every 2 months.
Aristada was initially approved by the Food and Drug Administration (FDA) in October 2015 as the first long-acting atypical antipsychotic for the treatment of schizophrenia with both once-monthly and 6-week dosing options.
Full results from the study will be presented at an upcoming medical meeting, while the results will be submitted to a peer-reviewed journal for publication. Based on these findings, Alkermes plans to submit a supplemental New Drug Application (sNDA) to the FDA in the second half of 2016.
For more information call (866) 274-7823 or visit Aristada.com.