NDA for Long-Acting Injectable for Schizophrenia and Bipolar I Accepted

The FDA has accepted the NDA for aripiprazole 2-month, ready-to-use, long-acting injectable.

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults. It is intended for dosing every 2 months via intramuscular injection in the gluteal muscle.

If approved, it would be the first 2-month LAI antipsychotic indicated for both the treatment of schizophrenia and the maintenance treatment of bipolar I disorder in the United States.

“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. The trial results reinforce the long-standing efficacy and safety profile of the once-monthly aripiprazole long-acting injectable,” said Johan Luthman, executive vice president, Lundbeck Research & Development.1

The 2-month long-acting injectable of aripiprazole in 960 mg and 720 mg prefilled syringes will deliver sustained plasma concentrations similar to that demonstrated in studies with aripiprazole once-monthly long-acting injectable.

“Stability is critical for patients with schizophrenia and bipolar I – which means delaying time to relapse or recurrence and supporting their role as functioning members of their community,” said Robert McQuade, PhD, executive vice president and chief strategy officer of Otsuka Pharmaceutical Development & Commercialization. “As we continue our efforts to bring aripiprazole 2-month to market, we remain committed to our patients and confident that the favorable safety and tolerability profile will be clearly visible.”

The FDA target date for review completion is April 27, 2023.

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Reference

1. 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. News release. Business Wire. 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