• First FDA approved, once-monthly, long-acting injectable for the maintenance monotherapy treatment of bipolar I disorder in adults1,2
  • New indication for ABILIFY MAINTENA is based on studies evaluating efficacy and safety in adult patients with bipolar I disorder1

TOKYO, Japan & VALBY, Denmark I July 28, 2017 I Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S today announced ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension was approved by the U.S. Food and Drug Administration for the maintenance monotherapy treatment of bipolar I disorder (BP-I) in adults.1

ABILIFY MAINTENA is a once-monthly injectable formulation for intramuscular use created by Otsuka and has been co-developed and co-commercialized with Lundbeck. 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

“Bipolar I disorder is a recurrent chronic mental illness. 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. “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.”

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis. ABILIFY MAINTENA is contraindicated with a known hypersensitivity reaction to aripiprazole (see Important Safety Information below).

For more information about ABILIFY MAINTENA, please visit: https://www.abilifymaintena.com/.

About the Clinical Trial

The Phase 3 clinical trial supporting regulatory approval demonstrated the efficacy and safety of ABILIFY MAINTENA in the maintenance monotherapy treatment of BP-I. The study included patients who were experiencing a manic episode at trial entry and met DSM-IV-TR criteria for bipolar I disorder. In addition, patients had a history of at least one previous manic or mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalization and/or treatment with a mood stabilizer, and/or treatment with an antipsychotic agent. The clinical trial was a 52-week, double-blind, placebo-controlled, randomized withdrawal trial in adults with BP-I aged 18 to 65 years, who were stabilized with ABILIFY MAINTENA prior to randomization.1 The primary endpoint demonstrated ABILIFY MAINTENA significantly delayed time to recurrence of any mood episode during a 52-week treatment study compared with placebo.1 The trial demonstrated significant differences between treatment groups in delaying time to recurrence of both manic and mixed episodes but no substantial difference in depressive mood episodes.1

About ABILIFY MAINTENA® (aripiprazole)

ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension is an atypical antipsychotic for intramuscular use. It was created by Otsuka in Japan and has been co-developed and co-commercialized by the alliance between Otsuka and Lundbeck. ABILIFY MAINTENA was approved in the U.S. in 2013 for the treatment of adults with schizophrenia.1 ABILIFY MAINTENA is a sterile lyophilized powder that when reconstituted with sterile water for injection, forms a suspension that can be administered by injection once a month (the initial injection is accompanied by an overlapping 14-day dosing of oral antipsychotic treatment). Subsequent doses of ABILIFY MAINTENA provide uninterrupted medication coverage for up to 30 days.1 Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a therapeutic range for extended periods of time.1-2

The most commonly observed adverse reactions with ABILIFY MAINTENA in patients with schizophrenia (incidence of 5 percent or greater and aripiprazole incidence at least twice that for placebo) were increased weight, akathisia, injection site pain, and sedation.1

About Bipolar I Disorder

BP-I is a chronic mental illness with a 12-month and lifetime prevalence of 1.5 percent and 2.1 percent, respectively.3,4 People with BP-I experience one or more episodes of mania, and may have episodes of both mania and depression.3,5

INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFY MAINTENA® (aripiprazole)

INDICATIONS

ABILIFY MAINTENA is an atypical antipsychotic indicated for:

  • Treatment of schizophrenia in adults
  • Maintenance monotherapy treatment of bipolar I disorder in adults
REFERENCES:
1.   ABILIFY MAINTENA® (aripiprazole) 2017 full prescribing information.
2.   RISPERDAL CONSTA® (risperidone) 2017 prescribing information. Janssen. https://www.janssencns.com/shared/product/risperdalconsta/prescribing-information.pdf
3.   Bipolar Disorder. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Mental-Health-Conditions/Bipolar-Disorder. Accessed September 27, 2016.
4.   Epidemiology of DSM-5 bipolar I disorder: Results from the national epidemiologic survey on alcohol and related conditions – III. Blanco C, Compton WM, Saha TD et al. J Psychiatr Res 84 (2017) 310-317.
5.   National Institute of Mental Health. Serious Mental Illness (SMI) Among U.S. Adults. https://www.nimh.nih.gov/health/statistics/prevalence/serious-mental-illness-smi-among-us-adults.shtml. Accessed June 10, 2017.
 

About Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on Twitter at @OtsukaUS.

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease.

An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders — we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.

Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China and Denmark and production facilities in China, Denmark, France and Italy. Lundbeck generated revenue of DKK 15.6 billion in 2016 (EUR 2.1 billion; USD 2.3 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck.

About Lundbeck in the U.S.

In the U.S., Lundbeck employs nearly 900 people focused solely on accelerating therapies for brain disorders. With a special commitment to the lives of patients, families and caregivers, Lundbeck U.S. actively engages in hundreds of initiatives each year that support our patient communities.

SOURCE: Otsuka Pharmaceuticals