FDA Accepts NDA for Longer-Acting Aripiprazole


Aripiprazole, currently available as a once-monthly injection under the brand name Abilify Maintena, is being reviewed as a two-month therapy. The FDA target date for completion of the review is April 27, 2023.

The FDA has accepted Otsuka’s/Lundbeck’s new drug application (NDA) for aripiprazole to treat schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults. The FDA target date (PDUFA date) for completion of the review is April 27, 2023.

The therapy is a long-acting medication intended for dosing every two months via intramuscular injection. If approved, it will be available in 960 mg and 720 mg prefilled syringes. It will deliver sustained plasma concentrations similar to that demonstrated in studies with aripiprazole once-monthly long-acting injectable. It is intended for the populations as the once-a-month Abilify Maintena (aripiprazole).

The NDA is supported by a 32-week bridging trial in which aripiprazole two-month showed comparable effectiveness and consistent safety profile to aripiprazole one-month. The 960 mg dosage aripiprazole two-month met the primary endpoint criteria establishing similarity of aripiprazole plasma concentrations and thus comparable effectiveness to aripiprazole once-monthly 400 mg over a two-month dosing interval. The therapy was generally safe and well tolerated and patients did not show any new safety concerns compared with aripiprazole once-monthly 400 mg.

Johan Luthman

Johan Luthman

“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. The trial results reinforce the long-standing efficacy and safety profile of the once-monthly aripiprazole long-acting injectable,” Johan Luthman, executive vice president, Lundbeck Research & Development, said in a press release.

Schizophrenia is a severely debilitating mental illness characterized by delusions, hallucinations, and disordered cognition. The prevalence of schizophrenia in 2019 was estimated to be about 0.3%. Medication adherence in patients with schizophrenia is generally poor and several studies have demonstrated that the strongest predictor of further relapse is nonadherence with antipsychotic medications.

Bipolar I disorder is a recurrent, lifelong mood disorder with a variable course that results in functional and cognitive impairment and a reduction in quality of life that affects 0.6% of the population. The course of bipolar I disorder is characterized by recurrent manic and depressive episodes that may last weeks or months. More than 90% of people with bipolar disorder experience recurrences during their lifetime.

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