FDA Accepts New Drug Application for Aripiprazole Long-Acting Injectable for Schizophrenia, Bipolar Disorder

The New Drug Application for aripiprazole 2-month, ready-to-use, long-acting injectable could lead to the first FDA approval of a 2-month schizophrenia and bipolar I disorder antipsychotic treatment.

The FDA has accepted a New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable (LAI) to treat adults with schizophrenia. The FDA also accepted the drug’s NDA to be used as a maintenance monotherapy for bipolar I disorder. The decision was announced by Otsuka America Pharmaceutical, Inc, and H. Lundbeck A/S.

If approved, aripiprazole 2-month, ready-to-use LAI would be available in either a 960 mg or 720 mg prefilled syringe administered as an intramuscular injection into the gluteal muscle every 2 months. The delivered and sustained plasma concentrations will be similar to those in the once-monthly LAI.

“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, in a press release. “The trial results reinforce the long-standing efficacy and safety profile of the once-monthly aripiprazole long-acting injectable.”

In clinical trial 031-201-00181, researchers evaluated the efficacy and safety of aripiprazole 2-month ready-to-use LAI for schizophrenia and bipolar I disorder. The primary endpoint was to demonstrate similar efficacy between aripiprazole 2-month ready-to-use LAI and aripiprazole once-monthly 400 mg over a 2-month dosing interval.

The investigators enrolled 266 participants in a 32-week-long bridging trial, which showed that aripiprazole ready-to-use LAI 960 mg was as effective as the 400 mg 1-month dose of aripiprazole.

Aripiprazole ready-to-use LAI at 960 mg did not raise new safety concerns compared to the 400 mg once-monthly dose. It was generally well tolerated and safe for patients with schizophrenia and bipolar I disorder.

Schizophrenia is characterized by acute episodes of psychotic behavior, with the most common symptoms being delusions, hallucinations, and disordered cognition. It is a severe and debilitating mental illness that, as of 2019, is estimated to affect about 0.3% of people worldwide. Although antipsychotic medications are available, adherence is often a challenge for patients.

Bipolar I disorder is a lifelong mood disorder that can be characterized by recurrent manic or depressive episodes, lasting for a range of weeks to months. Approximately 0.6% of the population are affected by this disease, with current and long-term pharmacologic treatments available to delay new episodes.

“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,” said Robert McQuade, PhD, executive vice president and chief strategy officer of Otsuka Pharmaceutical Development & Commercialization, Inc, in a press release.


Lundbeck. 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. Lundbeck website. September 13, 2022. Accessed on September 13, 2022. https://www.newsroom.lundbeckus.com/news-release/2022/otsuka-and-lundbeck-announce-fda-acceptance-of-nda-for-aripiprazole-2-month

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