FOR INTERNAL USE ONLY
JULY 2014
ABILIFY MAINTENA® (aripiprazole) MEDIA MATERIALS
Ideas for a feature/editorial article for a pharmacist audience
During the launch phase of Abilify Maintena® (aripiprazole), journalists writing for a healthcare professional
audience may have a particular interest in featuring information about the use of long-acting injectable
BOKSOVERSKRIFT 1
antipsychotics (LAIs) as a new once-monthly treatment option in the maintenance treatment of schizophrenia is
becoming available with Abilify Maintena.
Bokstekst - eller Bokspunktliste
Boksoverskrift 2
The factual content provided in this document can be used by Otsuka and Lundbeck affiliates (after local review,
translation and approval) when liaising with healthcare journalists. This document provides ideas for relevant
content that journalists may want to consider when developing an editorial* or a feature article** about the use of
LAIs in the treatment of schizophrenia and/or Abilify Maintena (as deemed appropriate by the journalist and their
publication).
*An editorial is an article written in a trade publication that presents the opinion of the publisher or editor(s). An editorial piece may focus on
covering the launch of the Abilify Maintena brand (brand names may be used by the author).
**A feature article is a special article written by a journalist or expert that is not necessarily tied to a recent news event. It can focus on particular
people, places, topics and events. A feature, in this case a feature aimed at pharmacists, may focus on providing information about the use of
LAIs and may mention that once-monthly aripiprazole is a newly available option in the maintenance treatment of schizophrenia (brand names
tend not to be used within feature articles).
In both instances, affiliates are to ensure that the content ideas they intend to share with the journalist are
submitted for local Otsuka/Lundbeck approval before approaching media outlets.
SUGGESTED TOPIC FOR EDITORIAL CONTENT
The role of long-acting injectable antipsychotics (LAIs) in the management of schizophrenia
FOCUS OF EDITORIAL CONTENT
A look at atypical long-acting antipsychotic injectable therapies as an option to reduce the hospitalisation and costly
management of people with schizophrenia
REASON FOR THE JOURNALIST TO CONSIDER THIS TOPIC
Prompted by the availability of the new long-acting antipsychotic Abilify Maintena, this article focuses on the use of
LAIs for the long-term management of schizophrenia, first introducing the aims of pharmacotherapy for
schizophrenia, then outlining the role of LAIs in the management of schizophrenia before reviewing the function
and mode of action of aripiprazole LAI in more detail (if appropriate for the publication).
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MEDIA OUTLET WITH A POTENTIAL INTEREST IN THIS EDITORIAL CONTENT
Hospital Pharmacy Europe is an example of a UK-based trade media outlet with a European reach.
TARGET AUDIENCE
Chief and senior pharmacists, medicines information pharmacists, directors of pharmacy, formulary committee
members and medicines-safety specialists and clinical pharmacists.
KEY POINTS TO HIGHLIGHT WHEN LIAISING WITH A JOURNALIST ON IDEAS FOR AN
EDITORIAL/FEATURE

Recurring relapses are common in schizophrenia and they result in decreased functioning and substantial
and lasting neurological damage1

The cycle of psychotic relapse, treatment failure, hospitalisation and incomplete recovery also leads to
substantial healthcare costs2

LAIs offer better treatment outcomes, with fewer relapses and hospitalisations, than oral antipsychotics 3,4

The consistent therapeutic drug levels achieved with LAIs offer physicians an objective way to asses
treatment efficacy as well as patient adherence, enabling them to intervene before symptoms exacerbate5

The newly approved aripiprazole LAI has shown efficacy in protecting from relapse and treating positive
and negative symptoms, as well as featuring a favourable tolerability profile 6,7

Aripiprazole LAI offers an additional treatment option for the maintenance treatment of schizophrenia 6
POTENTIAL SPOKESPERSON
Proposed spokespeople are opinion leaders with clinical and/or research experience in pharmacology and mental
health. Please note that spokespeople can be asked to author an editorial piece or provide comments and opinions
in relation to an editorial piece drafted by a journalist.
Proposed UK spokesperson:
David Taylor, Director of Pharmacy and Pathology at the Maudsley Hospital, Professor of Psychopharmacology at
King’s College and Honorary Professor at the Institute of Psychiatry. Dr Taylor often provides expert comment on
issues facing mental health across national and regional media. He has appeared on numerous television (Kilroy,
Panorama, Sky News, etc.) and radio programmes and has extensive experience of live interviews.
CONTENT TO BE PROPOSED TO THE JOURNALIST FOR THEIR CONSIDERATION AND CHOICE OF
ARTICLE
Background on the disease area

Schizophrenia is a complex, chronic and progressive mental health condition that typically emerges in late
adolescence or early adulthood8
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
The disorder affects around 24 million people worldwide8 and causes a range of symptoms such as
changes in behaviour, hallucinations, delusions and disorganised thoughts 9

The clinical deterioration associated with schizophrenia occurs predominantly during the first 5–10 years
after a patient’s first episode1

Although most individuals achieve symptomatic remission after their first episode, the majority proceeds to
have one or more relapses1

Recurring relapses result in decreased functioning and substantial and lasting neurological damage, which
may adversely affect a patient’s potential1,10
Current treatment approaches

While there is no cure, symptoms and the risk of relapse can be managed with appropriate treatment,
which may include pharmacotherapy, psychological interventions and educational programmes 11

In the UK [local adaptation required], NICE guidelines recommend that cognitive behavioural therapy
should be offered to people with schizophrenia and family interventions to the family and those who care
for people with schizophrenia12

Nevertheless, pharmacotherapy, which includes oral and long-acting injectable (LAI) antipsychotics,
remains the mainstay treatment11

Clinical practice guidelines recommend that the choice of antipsychotic be made between the healthcare
provider and the patient, taking into account the patient’s preferences and prior experience with
antipsychotic medication11,12
Unmet needs in the management of schizophrenia
Relapse prevention

The sequence of psychotic relapses, treatment failure and incomplete recovery can lead to persistent
disturbances and deficits in perception, thought processes and cognition for the patient 1,10

The nature of schizophrenia itself, including poor insight and cognitive deficits, can make it difficult for
patients to follow a daily treatment regimen13,14

A common reason for relapse is non-adherence to medication15, which significantly increases the risk of
hospitalisation16

Even small gaps in treatment can increase the risk of hospitalisation by two-fold17

Discontinuation of medication has also been associated with increased symptom severity, symptom
exacerbation, poor mental functioning and life satisfaction, as well as substance abuse18

In terms of costs to society, relapses result in high healthcare costs, mainly due to hospitalisations 2, and
costs associated with loss of productivity, which may arise from not completing an education or not
maintaining regular full-time employment19
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Treatment goals

Given the issues associated with recurring relapses, a major goal in the management of schizophrenia is to
protect patients from relapse1

Minimising the risk of relapse early in the course of the illness may help to minimise the negative impact
that recurring relapses have on a patient’s long-term prognosis1,20
Pharmacotherapy
 Pharmacotherapy has long been a cornerstone in the long-term management of schizophrenia, including
both oral and LAI antipsychotics15

In instances where antipsychotics have similar efficacy, the evidence suggests that safety and tolerability
profiles should be taken into consideration when selecting a treatment option12,15

The choice of pharmacotherapy should be evaluated as part of a comprehensive package of care that
addresses the patient’s needs, their prior experience with medication and their emotional and social
needs12,15
The role of long-acting injectable antipsychotics

Poor insight into illness, side effects from pharmacotherapy, residual symptoms, a complicated treatment
regimen, frequent dosing, and/or the lack of family/carer support can all pose challenges for patients taking
daily oral antipsychotics13,14, and can ultimately lead to relapse

LAI antipsychotics may increase the probability that drug blood levels remain in the therapeutic range 4,21
and allow for more objective evaluations of efficacy than are possible with oral medications 5

LAI antipsychotics are designed to deliver a gradual release of the active agent into the blood plasma from
a single intramuscular injection22

All available atypical LAI antipsychotics have a simple dosing regimen, being administered either once 23,24
or twice a month25,26

In a meta-analysis of naturalistic studies including over 4,000 patients, LAI antipsychotics were found to
significantly reduce the risk of hospitalisation compared with oral antipsychotics. Sixty two percent of
patients experienced fewer hospitalisations compared with those receiving oral antipsychotics 27

Evidence highlighting the advantages of LAIs over oral antipsychotics include: the simplification of the
treatment process by eliminating the daily need to take medication28; elimination of covert non-adherence3;
protection against relapse29; and a reduction of loss of function associated with multiple cycles of relapse
and rehospitalisation22

LAIs may be beneficial for patients with first-episode psychosis30; in patients hospitalised for the first time,
the use of LAIs reduced the risk of readmission by 64% compared with oral formulations 31

Despite reducing the risk of relapse, LAIs are not widely used in routine clinical practice 32. Many clinicians
view LAIs as coercive, stigmatising, unacceptable for patients or impossible to stop immediately when side
effects occur32. However, patients who received both oral and LAI antipsychotics have expressed higher
satisfaction with LAIs than with oral antipsychotics, as have their caregivers 6,33
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Currently available long-acting treatment options

There are four atypical antipsychotics currently available in the EU as LAIs for the treatment of
schizophrenia: risperidone, paliperidone, olanzapine and aripiprazole 23-26

All four have shown efficacy in the maintenance treatment of schizophrenia 6,34-36. However, each agent has
a defined side effect profile
Aripiprazole LAI

Aripiprazole LAI is the fourth and most recent LAI to become available in the EU 37

Clinical evidence showed that aripiprazole LAI provided patients with long-term efficacy and was noninferior to oral aripiprazole24

The estimated relapse rate by the end of week 26 was 7.1% with aripiprazole LAI and 7.8% with oral
aripiprazole7

Additional clinical evidence showed a significantly lower proportion of patients experiencing impending
relapse with aripiprazole LAI (10.0%; n=27/269) versus placebo (39.6%; n=53/134) (p<0.0001) 6, and
aripiprazole LAI maintained improvements in positive and negative symptoms compared with placebo as
assessed by the Positive and Negative Score Scale over 52 weeks 6

Common adverse events reported by ≥5% of patients with aripiprazole LAI were weight gain (9.0%),
akathisia (7.9%), insomnia (5.8%) and injection site pain (5.1%)24
[Information provided must always be in compliance with local rules and legislation. Local rules and
regulations may limit the amount of information that can be provided on a specific product, in this case
Abilify Maintena. Information should be balanced. Carefully consider this when reviewing and adapting
locally.]
Mode of action

Aripiprazole LAI is the first LAI formulation of a partial agonist to dopamine D2 and serotonin 5-HT1A
receptors to be developed for the treatment of schizophrenia24
Administration and dosing

The recommended starting and subsequent maintenance dose is 400 mg aripiprazole LAI, once a month
via intramuscular administration24

To maintain therapeutic antipsychotic concentrations during the initiation of therapy, treatment should be
continued for 14 consecutive days with 10–20 mg oral aripiprazole24

For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to
initiating treatment with aripiprazole LAI24

A 300 mg dose of aripiprazole LAI is available for patients who experience tolerability concerns 24
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References
1.
Lieberman JA, et al. Biol Psychiatry. 2001;50:884-97.
2.
Gilmer TP, et al. Am J Psychiatry. 2004;161:692-9.
3.
Citrome L. Patient Prefer Adherence. 2009;3:345-55.
4.
Agid O, et al. Expert Opin Pharmacother. 2010;11:2301-17.
5.
Barnes TR Curson DA. Drug Saf. 1994;10:464-79.
6.
Kane JM, et al. J Clin Psychiatry. 2012;73:617-24.
7.
Fleischhacker WW, et al. Br J Psychiatry. 2014;doi: 10.1192/bjp.bp.113.134213
8.
WHO. What is schizophrenia? (2011) [Accessed January 2014]. Available from:
http://www.who.int/mental_health/management/schizophrenia/en/.
9.
National Health Service (NHS). Schizophrenia. (2012) [Accessed January 2014]. Available from:
http://www.nhs.uk/conditions/schizophrenia/pages/introduction.aspx.
10.
Lieberman JA, et al. CNS Spectr. 2006;11:suppl 1-13; quiz suppl 4-5.
11.
Hasan A, et al. World J Biol Psychiatry. 2013;14:2-44.
12.
National Institute for Health and Clinical Excellence (NICE). Schizophrenia: Core interventions in the
treatment and management of schizophrenia in adults in primary and secondary care (CG82). (2009)
[Accessed February 2014]. Available from: guidance.nice.org.uk/cg82.
13.
Perkins DO. J Clin Psychiatry. 2002;63:1121-8.
14.
Quach PL, et al. Early Interv Psychiatry. 2009;3:66-74.
15.
Hasan A, et al. World J Biol Psychiatry. 2012;13:318-78.
16.
Valenstein M, et al. J Clin Psychiatry. 2006;67:1542-50.
17.
Weiden PJ, et al. Psychiatr Serv. 2004;55:886-91.
18.
Velligan DI, et al. J Clin Psychiatry. 2009;70 Suppl 4:1-46; quiz 7-8.
19.
Wu EQ, et al. J Clin Psychiatry. 2005;66:1122-9.
20.
Boyer L, et al. BMC Psychiatry. 2013;13:15.
21.
Patel M David A. Adv Psychiatr Treat. 2005;11:203-13.
22.
Weiden PJ, et al. Psychiatric Annals. 2011;41.
23.
Jassen Cilag. Paliperidone palmitate summary of product characteristics. (2014) [Accessed July 2014].
Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002105/human_med_0
01424.jsp&mid=WC0b01ac058001d124.
24.
Otsuka Pharmaceuticals. Abilify maintena (aripiprazole once-monthly injection) summary of product
characteristics. (2013) [Accessed July 2014]. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002755/human_med_0
01711.jsp&mid=WC0b01ac058001d124.
25.
Eli Lilly and Co Ltd. Olanzapine pamoate (Zypadhera) summary of product characteristics. (2014)
[Accessed July 2014]. Available from:
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http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000890/human_med_0
01188.jsp&mid=WC0b01ac058001d124.
26.
Jassen-Cilag Ltd. Risperidone long-acting injectable (Risperdal Consta) Summary of Product
Characteristics. (2013) [Accessed July 2014]. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Risperdal_Consta/human
_referral_000027.jsp.
27.
Kishimoto T, et al. J Clin Psychiatry. 2013;74:957-65.
28.
Gutierrez-Casares JR, et al. CNS Spectr. 2010;15:327-37.
29.
Leucht C, et al. Schizophr Res. 2011;127:83-92.
30.
Zhornitsky S Stip E. Schizophr Res Treatment. 2012;2012:407171.
31.
Tiihonen J, et al. Am J Psychiatry. 2011;168:603-9.
32.
Llorca PM, et al. BMC Psychiatry. 2013;13:340.
33.
Han C, et al. Primary Care and Community Psychiatry. 2005;10:119–24.
34.
Hough D, et al. Schizophr Res. 2010;116:107-17.
35.
Kane JM, et al. Am J Psychiatry. 2010;167:181-9.
36.
Simpson GM, et al. J Clin Psychiatry. 2006;67:1194-203.
37.
European Medicines Agency (EMA). EPAR summary. (2013) [Accessed January 2014]. Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Summary_for_the_public/human/002755/WC500156106.pdf.
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