FDA approves long-acting injectable for schizophrenia, bipolar I disorder

Key takeaways:

• The FDA approved a new drug application for a treatment for schizophrenia or bipolar I disorder.
• The injectable suspension is administered once every 2 months.

The FDA has approved a new drug application for aripiprazole, an extended-release injection for the treatment of schizophrenia and bipolar disorder, according to a press release from the manufacturers.

The approval is based on positive results from a 32-week randomized, parallel-arm multicenter study that included 266 participants with schizophrenia and bipolar I disorder, according to the release.

Specifically, the aripiprazole intramuscular injection (Abilify Asimtufii, Otsuka America Pharmaceutical and H. Lundbeck A/S) is indicated as a treatment for schizophrenia in adults or as a maintenance monotherapy for bipolar I disorder in adults.

Each dose comes in a syringe prefilled with 960 mg or 720 mg of Abilify Asimtufii, which is administered by a health care professional into the gluteal muscle once every 2 months. The drug works by continuously delivering medication and maintaining therapeutic plasma levels, according to the release.

“This approval is important news for patients, families and health care providers,” Johan Luthman, DDS, PhD, executive vice president of research and development at Lundbeck, said in the release. “We hope that the use of Abilify Asimtufii in treatment plans will have a positive impact on those living with schizophrenia or bipolar I disorder.”