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.
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