Abilify Asimtufii FDA Approval History
Last updated by Judith Stewart, BPharm on May 1, 2023.
FDA Approved: Yes (First approved April 27, 2023)
Brand name: Abilify Asimtufii
Generic name: aripiprazole
Dosage form: Extended-Release Injectable Suspension
Company: Otsuka Pharmaceutical Co., Ltd
Treatment for: Schizophrenia, Bipolar Disorder
Abilify Asimtufii (aripiprazole) is a long-acting injectable atypical antipsychotic for the treatment of schizophrenia and bipolar I disorder.
- Abilify Asimtufii is indicated for the treatment of schizophrenia in adults, and as maintenance monotherapy treatment of bipolar I disorder in adults.
- Aripiprazole is an atypical antipsychotic that is thought to work through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors.
- Aripiprazole was first approved under the brand name Abilify as an oral tablet formulation in 2002, followed by Abilify oral solution in 2004 (now discontinued), Abilify Discmelt orally disintegrating tablets in 2006 (now discontinued), and Abilify intramuscular injection in 2006 (now discontinued). Abilify Maintena extended-release injectable suspension was approved in 2013 for once-monthly administration via intramuscular injection. The Abilify MyCite tablet formulation embedded with an ingestible Proteus® sensor for communication with a wearable sensor patch and a medical software application was approved in 2017.
- Abilify Asimtufii is administered via intramuscular injection once every 2 months. For patients who have not been previously treated with aripiprazole, tolerability needs to be established with oral aripiprazole prior to initiating treatment with Abilify Asimtufii.
- The Abilify Asimtufii product label carries a Boxed Warning for increased risk of death in elderly patients with dementia-related psychosis. Warnings and precautions associated with Abilify Asimtufii include increased incidence of cerebrovascular adverse reactions in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; tardive dyskinesia; metabolic changes; pathological gambling and other compulsive behaviors; orthostatic hypotension and syncope; leukopenia, neutropenia, and agranulocytosis; seizures; and potential for cognitive and motor impairment.
- Common adverse reactions include increased weight, akathisia, injection site pain, and sedation.
Development timeline for Abilify Asimtufii
| Date | Article |
|---|---|
| Apr 28, 2023 | Approval FDA Approves Abilify Asimtufii (aripiprazole) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults |
Further information
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