The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults.

The investigational formulation is intended for dosing every 2 months via intramuscular injection in the gluteal muscle and does not require reconstitution. It will be provided in 720mg and 960mg single-chamber, prefilled syringes. 

The NDA is supported by data from an open-label, multiple-dose, parallel-arm phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04030143) that evaluated the safety and tolerability of multiple dose administrations of aripiprazole in 266 adults with schizophrenia or bipolar I disorder. Patients were randomly assigned to receive either a total of 4 injections of aripiprazole 2-month, long-acting injectable or a total of 8 injections of aripiprazole 1-month depot.

Results showed that treatment with 960mg of aripiprazole 2-month, ready-to-use, long-acting injectable met the primary endpoint achieving similar aripiprazole plasma concentrations and comparable efficacy to aripiprazole once-monthly 400mg. Treatment with the 2-month injectable was found to be safe and well tolerated; no new safety concerns were reported with multiple administrations.

“This is an important milestone in our efforts to offer adult patients with schizophrenia or bipolar I disorder a new option designed to support treatment goals and offer greater flexibility,” said Johan Luthman, executive vice president, Lundbeck Research & Development. “The trial results reinforce the long-standing efficacy and safety profile of the once-monthly aripiprazole long-acting injectable.”

A Prescription Drug User Fee Act target date of April 27, 2023 has been set for the application.

Reference

Otsuka and Lundbeck announce US FDA acceptance of New Drug Application for aripiprazole 2-month, ready-to-use, long-acting injectable to treat schizophrenia and bipolar I disorder in adults. News release. Otsuka America Pharmaceutical, Inc., and H. Lundbeck A/S. Accessed September 13, 2022. https://www.businesswire.com/news/home/20220913005499/en/Otsuka-and-Lundbeck-Announce-U.S.-FDA-Acceptance-of-New-Drug-Application-for-Aripiprazole-2-month-Ready-to-Use-Long-acting-Injectable-to-Treat-Schizophrenia-and-Bipolar-I-Disorder-in-Adults