The new drug application for aripiprazole, ready-to-use, 2-month long-acting injectable, could lead to the first 2-month FDA approval of an antipsychotic treatment for schizophrenia and bipolar I disorder.
The FDA has approved a New Drug Application (NDA) for 2-month ready-to-use, long-acting injectable (LAI) aripiprazole for the treatment of 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, the ready-to-use LAI of aripiprazole would be available for 2 months in a 960 mg or 720 mg pre-filled syringe administered as an intramuscular injection into the gluteal muscle every 2 months. Delivered and sustained plasma concentrations will be similar to those in the once-monthly LAI.
“This is an important milestone in our effort to provide adult patients with schizophrenia or bipolar I disorder with a new option designed to support treatment goals and provide greater flexibility,” said Johan Luthman, executive vice president, Lundbeck Research & Development , in a press release. . “The study results reinforce the long-standing efficacy and safety profile of the once-monthly long-acting aripiprazole injection.”
In clinical study 031-201-00181, investigators evaluated the efficacy and safety of aripiprazole, ready-to-use LAI for 2 months for schizophrenia and bipolar I disorder. The primary endpoint was the demonstration of comparable efficacy between aripiprazole, 2-month ready-to-use LAI and aripiprazole 400 mg once monthly over a 2-month dosing interval.
The researchers enrolled 266 participants in a 32-week bridging study, which found that aripiprazole’s 960 mg ready-to-use LAI was as effective as the 400 mg dose of aripiprazole for 1 month.
Aripiprazole, 960 mg ready-to-use LAI, did not raise any 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, the most common symptoms of which are delusions, hallucinations, and impaired cognition. It is a serious and debilitating mental illness that is estimated to affect about 0.3% of people worldwide as of 2019. Although antipsychotics 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 weeks to months. About 0.6% of the population is affected by this disease, with current and long-term pharmacological treatments to delay new episodes.
“As we continue our efforts to bring aripiprazole to market for 2 months, we remain committed to our patients and are confident that its favorable safety and tolerability profile will be evident,” 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 US FDA acceptance of a new drug application for Aripiprazole, a 2-month ready-to-use, long-acting injection for the treatment of schizophrenia and bipolar I disorder in adults. Lundbeck website. September 13, 2022. Accessed September 13, 2022. https://www.newsroom.lundbeckus.com/news-release/2022/otsuka-and-lundbeck-announce-fda-acceptance-of-nda-for-aripiprazole- 2 month