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  5. U.S. FDA Approves The Labeling Update Of Abilify Maintena ® (Aripiprazole) For Extended-Release Injectable Suspension To Describe New Clinical Data For The Treatment Of Acutely Relapsed Adults With Schizophrenia

December 8, 2014

Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S

Pharmaceuticals

U.S. FDA Approves The Labeling Update Of Abilify Maintena ® (Aripiprazole) For Extended-Release Injectable Suspension To Describe New Clinical Data For The Treatment Of Acutely Relapsed Adults With Schizophrenia

  • Labeling update provides description of controlled clinical study of Abilify Maintena for treating adult patients experiencing acute relapses of schizophrenia
  • Approval was based on Abilify Maintena demonstrating efficacy, tolerability and safety in a 12-week study in acutely relapsed adults with schizophrenia
  • Pivotal efficacy results were published in the November print edition of The Journal of Clinical Psychiatry

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration (FDA) approved the labeling update of Abilify Maintena® (aripiprazole) for extended-release injectable suspension. The approval was based on results from a controlled clinical study of acutely relapsed adults with schizophrenia. Efficacy was demonstrated in a 12-week randomized, double-blind, placebo-controlled study, which showed treatment with Abilify Maintena (with concomitant oral aripiprazole for the first two weeks) significantly improved symptoms with an acceptable safety and tolerability profile in adult patients experiencing an acute relapse of schizophrenia.*1 These data were published in the November print edition of The Journal of Clinical Psychiatry.*2

Abilify Maintena, an atypical antipsychotic, was first approved by the FDA in February 2013 for intramuscular (gluteal) use for the treatment of schizophrenia. Efficacy was demonstrated in a placebo-controlled, randomized withdrawal maintenance trial in adult patients with schizophrenia, and additional support for efficacy was derived from oral aripiprazole trials.*1,3

"An acute exacerbation of psychotic symptoms, also referred to as disease relapse, is a key consideration in the management of schizophrenia, and can occur when a patient no longer responds to or stops taking antipsychotic medication,"*4 said study investigator John M. Kane, M.D., Chairman of Psychiatry, The Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. "These data - and the updated product labeling - confirm the utility of Abilify Maintena in acutely relapsed adult patients, giving physicians an option to consider for both the initial and ongoing treatment of patients with schizophrenia."*1

Clinical Trial Results

Efficacy of Abilify Maintena (aripiprazole) for the treatment of acutely relapsed adults with schizophrenia was demonstrated in a 12-week multicenter, randomized, double-blind, placebo-controlled trial. The primary measure used for assessing psychiatric signs and symptoms was the Positive and Negative Syndrome Scale (PANSS), a 30-item scale that measures positive and negative symptoms of schizophrenia and general psychopathology, using a rating scale of 1 (absent) to 7 (extreme); the primary endpoint was pre-specified to be measured as the change from baseline to week 10 of treatment. All patients entering the trial were inpatients who met DSM-IV-TR criteria for schizophrenia nd experienced an acute psychotic episode as defined by both PANSS total score of 80 or higher, and a PANSS score greater than 4 on each of four specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, unusual thought content). Patients had a mean PANSS total score of 103 at study entry.*1

A total of 339 patients received double-blind treatment with Abilify Maintena 400 mg (n=167) or placebo (n=172), with 64.3% (Abilify Maintena) and 49.4% (placebo) of patients completing 10 weeks of treatment. The primary efficacy outcome was change from baseline to 10-week endpoint in PANSS total score and demonstrated greater improvement with Abilify Maintena than with placebo (-26.8 vs. -11.7, respectively, p<0.0001): statistically significant improvements with Abilify Maintena were shown at all time points measured from week 1-12.*1 The key secondary efficacy outcome was change from baseline to 10-week endpoint in Clinical Global Impression Severity of Illness Scale (CGI-S) score and also showed statistically greater improvement with Abilify Maintena than with placebo (-1.4 vs. -0.6, respectively, p<0.0001).*1

Safety of Abilify Maintena

The overall safety and tolerability profile of Abilify Maintena in this study was generally consistent with that observed in previous double-blind phase III studies.*4,5 The most common reason for discontinuation at week 10 was patient withdrawal of consent in the Abilify Maintena group (19% vs. 9% for placebo) and lack of efficacy in the placebo group (29% vs. 7% for Abilify Maintena). Discontinuations due to adverse events occurred in 4% of patients receiving Abilify Maintena vs. 8% of patients receiving placebo.*2 Common adverse reactions (≥5% and with an incidence at least 2-times greater than placebo) were increased weight (16.8% vs. 7.0%), akathisia (11.4% vs. 3.5%), sedation (5.4% vs. 1.2%) and injection site pain (5.4% vs. 0.6%).*1

About Abilify Maintena® (aripiprazole)

Abilify Maintena (aripiprazole once-monthly) is the first and only once-monthly injection of a dopamine D2 partial agonist. It is available in the U.S. for the treatment of schizophrenia and in a number of European countries for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. In Canada it is available for the maintenance treatment of schizophrenia in stabilized adult patients and in Australia for maintenance of clinical improvement in the treatment of schizophrenia.

Abilify Maintena, an atypical antipsychotic, is an intramuscular depot formulation of aripiprazole. It is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. After an initial injection of Abilify Maintena along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of Abilify Maintena provide uninterrupted medication coverage for 30 days at a time. It provides a treatment option to address one of the most important considerations in the management of schizophrenia -- reducing the risk of relapse, or the re-emergence of worsening of symptoms. Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a therapeutic range for an extended period of time.*2,4

About Schizophrenia

Schizophrenia is a disease characterized by a distortion in the process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood and the condition is chronic, often requiring life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of the adult population in the U.S., and approximately 24 million people worldwide.*6,7 In the U.S., there are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders.*8,9 While there is no cure for the disease, symptoms and risk of relapse - the re-emergence or worsening of psychotic symptoms*10 - can be managed in most patients with appropriate antipsychotic treatment.

  • *1 Prescribing Information. ABILIFY MAINTENA®(aripiprazole) for extended-release injectable suspension, for intramuscular use. December 2014.
  • *2 Kane J., et al. Aripiprazole Once-Monthly in the Acute Treatment of Schizophrenia: Findings From a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study. Journal of Clinical Psychiatry. 2014;75 (11): 1254-1260.
  • *3 Drug Approval Reports. U.S. Food and Drug Administration (FDA). 2013. Available at:
    http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.MonthlyApprovalsAll. Accessed Accessed November 11, 2014.
  • *4 Kane J., et al. Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia: A 52-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Journal of Clinical Psychiatry. 2012; 73: 617-624.
  • *5 Fleischhacker W., et al. Aripiprazole Once-Monthly for the Treatment of Schizophrenia: A Double-Blind, Randomized, Non-Inferiority Study vs. Oral aripiprazole. The British Journal of Psychiatry. 2014; 205:135-144.
  • *6 Mental Health Information: Schizophrenia. National Institute of Mental Health. 2014. Available at:http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed on November 11, 2014.
  • *7 Schizophrenia Fact Sheet. World Health Organization. 2010. Available at http://www.who.int/mental_health/management/schizophrenia/en/. Accessed on November 11, 2014.
  • *8 National Institutes of Mental Health (NIMH). The Numbers Count: Mental Disorders in America. Available at http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america/index.shtml. Accessed May 14, 2013.
  • *9 Mental Illness Facts and Numbers. National Alliance on Mental Illness. 2013. Available at: http://www.nami.org/factsheets/mentalillness_factsheet.pdf. Accessed October 29, 2014.
  • *10 Almond, S., et al. Relapse in Schizophrenia: Costs, Clinical Outcomes and Quality of Life. British Journal of Psychiatry. 2004; 184: 346-351.

Information in this news release was current as of the original release date.

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