Aristada (aripiprazole lauroxil) extended-release injectable suspension filed with FDA for the treatment of schizophrenia- Alkermes

Alkermes announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for a two-month dosing interval of Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. This potential new two-month offering would expand the range of Aristada dosing intervals to include a third option for patients with schizophrenia. Aristada was approved by the FDA in October 2015 as the first long-acting atypical antipsychotic with once-monthly and once-every-six-weeks dosing options.

The sNDA for Aristada is based on the positive results from a recent randomized, open-label trial that assessed the pharmacokinetics (PK), safety and tolerability of Aristada when administered at the investigational two-month interval and at the FDA-approved dosing intervals of once monthly and once every six weeks. A total of 140 patients with stable schizophrenia were randomized to receive either 441 mg Aristada once per month, 882 mg Aristada every six weeks or 1064 mg Aristada every two months. Results from the study showed that the 1064 mg dose of Aristada achieved therapeutically relevant plasma concentrations of aripiprazole with a PK profile that supports dosing once every two months. The most common adverse event for the two-month dosing interval was injection site pain.