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ABILIFY MAINTENA is contraindicated with a known hypersensitivity reaction to aripiprazole (see Important Safety Information below).įor more information about ABILIFY MAINTENA, please visit. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis.

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“Receiving ABILIFY MAINTENA each month as prescribed and administered by a HCP, provides patients an opportunity to be free from taking their daily antipsychotic for bipolar I disorder it is important to note that concomitant oral antipsychotic must be administered for 14 days after the first injection.”Įlderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. ABILIFY MAINTENA provides healthcare professionals (HCPs) a new treatment option for their patients who have established tolerability with oral aripiprazole,” said Joseph Calabrese, MD, Director of the Mood Disorders Program at University Hospitals Cleveland Medical Center, and Professor of Psychiatry at Case Western Reserve University School of Medicine. “Bipolar I disorder is a recurrent chronic mental illness. Based on Phase 3 study data, ABILIFY MAINTENA delayed the time to recurrence of any mood episode in adult patients experiencing a manic episode at screening compared to placebo.1 Food and Drug Administration for the maintenance monotherapy treatment of bipolar I disorder (BP‑I) in adults.1ĪBILIFY MAINTENA is a once-monthly injectable formulation for intramuscular use created by Otsuka and has been co-developed and co-commercialized with Lundbeck. and H. Lundbeck A/S today announced ABILIFY MAINTENA ® (aripiprazole) for extended-release injectable suspension was approved by the U.S. (TOKYO, Japan & VALBY, Denmark, July 28, 2017) – Otsuka Pharmaceutical Co., Ltd.

New indication for ABILIFY MAINTENA is based on studies evaluating efficacy and safety in adult patients with bipolar I disorder1.

First FDA approved, once-monthly, long-acting injectable for the maintenance monotherapy treatment of bipolar I disorder in adults1,2.

More than 90% of people with bipolar disorder experience recurrences during their lifetime. The course of bipolar I disorder is characterized by recurrent manic and depressive episodes that may last weeks or months. 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.īipolar 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 prevalence of schizophrenia in 2019 was estimated to be about 0.3%. Schizophrenia is a severely debilitating mental illness characterized by delusions, hallucinations, and disordered cognition.

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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. “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 therapy was generally safe and well tolerated and patients did not show any new safety concerns compared with aripiprazole once-monthly 400 mg.

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

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