H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co, Ltd. (Otsuka) have announced marketing authorisation approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia.(1,2) It has a tolerability profile similar to oral aripiprazole,(1) and demonstrated statistically significant benefits on patients’ personal and social functioning as compared to placebo.(1,4)
Ninety-three percent of patients treated with Abilify Maintena were extremely, very or somewhat satisfied with their treatment at the end of the double-blind treatment phase.(4)
“We strongly believe the schizophrenia community will welcome the availability of Abilify Maintena to help improve outcomes for patients living with schizophrenia. As a company, our focus is to develop treatments to help protect against relapse and preserve brain function,” said Ole Vahlgren, CEO & President, Otsuka Europe. “We must partner with health care professionals and caregivers to help patients get the best treatments that focus on reducing the risk of relapse.”
“Studies have shown that the early use of long-acting injectables can prevent a person with schizophrenia from experiencing a relapse,”(5) said Ole Chrintz, SVP International Markets & Europe, Lundbeck. “Efficacy is important, but a treatment for a chronic condition such as schizophrenia also needs to be well tolerated so patients will stay on it over the long-term. We believe Abilify Maintena meets this need.”(1–3)
About the studies
The efficacy of Abilify Maintena was demonstrated in two double-blind, phase III, randomised trials. The safety profile for Abilify Maintena was demonstrated to be similar to that of oral ABILIFY. The most frequently observed adverse drug reactions (ADRs) reported in ≥5% of patients in two double-blind controlled clinical trials of Abilify Maintena were weight increases (9.0%), akathisia (7.9%), insomnia (5.8%), and injection site pain (5.1%).(1,2)
About Abilify Maintena
Abilify Maintena is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorisation for maintenance treatment in schizophrenia. Physicians now have an alternative treatment option, with a tolerability profile comparable to the well-established oral ABILIFY, to address the on-going need to reduce the risk of relapse in patients with schizophrenia.
The European label states that Abilify Maintena is a powder and solvent for prolonged-release suspension for intra-muscular (IM) injection. It is a once-monthly formulation of aripiprazole in a sterile lyophilised powder that is reconstituted with sterile water. Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
After the first injection, treatment with 10mg to 20mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.
About schizophrenia and disease relapse
Schizophrenia is a disease characterised by a distortion in the process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganised 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 lifelong treatment to mitigate symptoms.
Relapse of schizophrenia refers to an exacerbation or acute psychotic break that is characterised primarily by the emergence of positive symptoms such as hallucinations, delusions and disordered thinking.(6)
Relapse can occur when a patient no longer responds to antipsychotic medication, does not take the medication as prescribed, or stops taking their medication altogether. There are many reasons patients stop taking their medication, including poor insight about their illness, side effects from current treatments, complicated medication regimen or lack of support from family.(7) Abilify Maintena is able to significantly reduce the risk of relapse in patients with schizophrenia1.
It has been estimated that schizophrenia affects approximately 1% of the adult population in the US and Europe, and approximately 24 million people worldwide.(8,9) In Europe there are approximately 4.4 million adults with schizophrenia,(10) prevalent equally in both genders.(11,12) While there is no cure for the disease, symptoms and risk of relapse can be managed in most patients with appropriate antipsychotic treatment. However, when the disease is not managed, patients are at increased risk of disease relapse, which can cause the re-emergence or worsening of psychotic symptoms.(13)
Schizophrenia places a significant burden on society. It is regarded among the most financially costly illnesses and is according to the World Health Organization (WHO), the 8th leading cause of DALYs (lost healthy years) worldwide among patients between the age of 15-449. With 50% of patients not receiving appropriate care and 80% of patients relapsing within the first five years,(14) there is a significant unmet need to be addressed in schizophrenia.
- Kane, JM et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2012;73(5):617-62
- Fleischhacker WW, Sanchez R, Perry PP, et al. Aripiprazole once-monthly for the treatment of schizophrenia: a double-blind, randomized, non-inferiority study vs. oral aripiprazole. Annual Meeting of the American Psychiatric Association, 18–22 May, 2013 (poster).
- Sanchez R, et al. Patient-reported Outcomes with Aripiprazole-Intramuscular-Depot for Long-term Maintenance Treatment in Schiziphrenia. NR6-42 2012 (poster)
- Carson WH, Perry P, Sanchez R, et al. Effects of a Once-Monthly Formulation of Aripiprazole on Secondary Efficacy Outcomes in Maintenance Treatment of Schizophrenia. Institute on Psychiatric Services meeting, October 4–7, 2012 (Poster)
- Long-acting injectable antipsychotics in the treatment of schizophrenia: their role in relapse prevention. Agid O, et al. Expert Opin. Pharmacother. (2010) 11(14):2301-2317
- Ayuso-Gutierrez JL, del Rio Vega JM. Factors influencing relapse in the long-term course of schizophrenia. Schizophr Res. 1997; 28(2-3): 199-206
- Baloush-Kleinman V, et al. Adherence to antipsychotic drug treatment in early-episode schizophrenia: a six-month naturalistic follow-up study. Schizophr Res. 2011;130(1-3):176-81.
- National Institute of Mental Health (NIMH). Health Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed October 22, 2013
- World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available at: http://www.who.int/mental_health/management/schizophrenia/en/. Accessed October 22, 2013.
- World Health Organization (WHO) The global burden of disease:2004 update (2008)
- National Institute of Mental Health (NIMH). The Numbers Count: Mental Disorders in America. 2010. Available at http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-dis…. Accessed October22, 2013
- Regier DA, et al. The de facto US mental and addictive disorders service system. Epidemiologic catchment area prospective 1-year prevalence rates of disorders and services. Arch Gen Psychiatry. 1993;50(2):85-94.
- American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. Second edition. 2004. Available at http://psychiatryonline.org/content.aspx?bookid=28§ionid=1665359. Accessed October 28, 2013
- Robinson D, et al. Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder. Arch Gen Psychiatry. 1999;56(3):241-247