FDA greenlights first bi-monthly injectable for schizophrenia, bipolar 1 disorder

Published: May 01, 2023

By Tristan Manalac


Friday, the FDA approved Otsuka and Lundbeck’s extended-release injectable formulation of aripiprazole, now to be marketed as Abilify Asimtufii, for the treatment of schizophrenia or as maintenance therapy for bipolar I disorder.

Abilify Asimtufii is the first long-acting injectable for these indications that only needs to be administered once every two months, according to the companies. The new formulation is approved for use in adult patients.

Otsuka and Lundbeck supported Abilify Asimtufii’s FDA bid with data from the pivotal 031-201-00181 trial, which compared its efficacy with another aripiprazole formulation, the 400-mg once-monthly Abilify Maintena, in the same indications.

Pharmacokinetic analyses showed that a 960-mg, once-every-two-month dosing regimen induced similar plasma aripiprazole concentrations as the once-per-month version, Abilify Maintena.

As for safety, the study found that even at multiple doses, the 960-mg Abilify Asimtufii dose is generally well-tolerated and has a similar adverse event profile to Abilify Maintena.

These results validate the established safety and efficacy profile of the once-monthly aripiprazole injection, while also enabling the companies to offer new treatment options that provide patients with schizophrenia and bipolar I disorder more flexibility, Johan Luthman, executive vice president, Lundbeck Research & Development, said in a statement.

In its approved form, Abilify Asimtufii comes in 960-mg and 720-mg prefilled syringes, both of which are designed to deliver doses that lead to sustained plasma levels of aripiprazole. The drug is delivered by a healthcare professional through an intramuscular injection to the gluteal muscle.

Abilify Asimtufii’s label contains a warning for an increased risk of death for elderly people who are experiencing psychosis due to dementia and are being treated with antipsychotic drugs. The drug might also lead to stroke, neuroleptic malignant syndrome, uncontrolled body movements and metabolic problems.

Friday’s approval pits Otsuka and Lundbeck against Johnson & Johnson in the schizophrenia market. In September 2021, J&J subsidiary Janssen won FDA approval for Invega Hafyera (paliperidone palmitate six-month), its long-acting injection for schizophrenia designed to be administered twice a year.

Data from a Phase III non-inferiority study found that Invega Hafyera was just as effective as a three-month formulation of paliperidone palmitate. Another study, dubbed Route 6, showed that the six-month formulation can prevent relapses in over 90% of patients throughout one year of treatment.

Source: BioSpace