Special Access Drugs

Aripiprazole (Abilify©)
Last updated December 2006

Introduction

Aripiprazole is the first of a new generation of antipsychotic drugs with a different

mechanism of action. It is considered the prototype of a new third generation of
antipsychotics, sometimes called the dopamine-serotonin stabilizers.
Its antipsychotic effects are thought to be due to partial agonist activity at the D2
dopamine and 5-HT1 serotonin receptors, as well as antagonism at 5-HT2
serotonin receptors. It has been postulated that as a partial D2 agonist, it acts as
an antagonist in dopamine pathways where there is abundance of dopamine and
as an agonist in pathways where there is low dopaminergic transmission - hence
its description as a dopamine serotonin system stabilizer. (Lawler C P 1999)
Aripiprazole also has effects at the D3, D4, 5-HT2c, 5-HT7, alpha-1 adrenergic
and H1 histamine receptor. (Lawler CP 1999)

Efficacy

In published studies, aripiprazole has been found to be at least as effective as

haloperidol for positive symptoms of schizophrenia such as delusions and
auditory hallucinations. It is also effective for negative symptoms of
schizophrenia, such as social withdrawal, apathy, amotivation and poverty of
thought. (Kane JM 2002) It has been found to be effective in both acute and
maintenance phases of schizophrenia and is said to have cognitive enhancing
effects. (Archibald DG 2003)

Adverse Effects

The most common adverse effects associated with aripiprazole are headache,
somnolence, agitation, dyspepsia, anxiety, and nausea. (Marder SR 2002)
Aripiprazole is associated with fewer movement disorders (parkinsonism,
akathisia, tardive dyskinesia) than first generation antipsychotics. It causes less
elevation of prolactin and less prolongation of the average QTc compared with
risperidone. (Rivas-Vasquez 2003) The average weight gain with aripiprazole is
less than with olanzapine, quetiapine or clozapine and is similar to haloperidol.
(Marder SR 2002)

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Cochrane Systematic Review (May 2006)

A systemic review of fifteen randomized aripiprazole studies, found that when

compared with olanzapine and risperidone, aripiprazole was no better or worse
on outcomes of global state and leaving the study early. Compared with first
generation antipsychotics, aripiprazole was associated with less akathisia and a
reduced need for antiparkinson medication; otherwise the rates of adverse
effects were similar.
There was insufficient data to compare adverse effects of weight gain, glucose
metabolism, or tardive dyskinesia. The review also had insufficient usable data
on death, service outcomes, general functioning, behavior, and engagement with
services, satisfaction with treatment, economic outcome or cognitive functioning.

Dose and availability

Recommended dose of aripiprazole is 10 – 15 mg per day (range 10 - 30 mg).

Aripiprazole is still an investigational drug in Canada and only available as a
Special Access Drug through Health Canada. It was granted Approvable Status
by the FDA (USA) in 2002 and is marketed by Bristol-Myers Squibb.

In British Columbia, funding is available while the client is hospitalized. Upon

discharge, funding must be applied for through Pharmacare on an individual
basis. See guidelines for obtaining aripiprazole for further information.

Cost

$12.03 per 15 mg tablet

Guidelines for Obtaining Aripiprazole in British Columbia

Inpatients:

Section 1

• An application for a “Special Access Drug” must be filled out for

aripiprazole. Forms can be obtained on the following link:

http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/sapf1_pasf1_e.html

Health Canada Special Access

o Phone: (613) 941-2108
o Fax: (613)941-3194

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 • The application must be accompanied by at least one reference on
aripiprazole.
• Fax the application and reference(s) to (613) 941-3194
• If the form is not filled out correctly, you will receive notification by fax.
• If a corrected version is not resubmitted, the drug will not be supplied.
• If the drug is not received within the specified time frame, it is advisable
to call Health Canada to follow-up on the reason(s) for the delay.
• A maximum of 60 X 15 mg tablets will be supplied per request.

Prior to Discharge

• Aripiprazole is not covered by pharmacare unless applied for on a case by

case basis.
• Phone pharmacare at 1-877-657-1188 to make a request for funding.
• Pharmacare has requested the following information to make decisions on
funding individual clients:

o Reason for request for aripiprazole

o Patient demographics i.e. age, gender, diagnosis
o Medication history (in particular antipsychotics)
o Response to antipsychotics including aripiprazole
o Number of previous hospitalizations (sometimes they have
requested length of stay as well)
• The approval has to be renewed every year.

After approval for funding from pharmacare

• If care of the patient is transferred to a different doctor in the community,

the steps outlined in section 1 have to be repeated by the new doctor.
• Health Canada will not send aripiprazole to a retail pharmacy. It has to be
delivered either to a doctor’s office or to a hospital.
• A Special Access Form (along with the references) has to be faxed from
the doctor’s office to Health Canada when the stock is to be replenished.

If you have any questions regarding the process for obtaining aripiprazole,
please phone Riverview Hospital Pharmacy at 604-524-7012.

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 References

Archibald DG, Manos G, Tourkodimetris S. et al. Reduction in negative

symptoms of schizophrenia during long-term therapy with aripiprazole.
Schizophrenia Research 2003; 60:271.

Kane JM, Carson WH, Saha AR et al. Efficacy and safety of aripiprazole and
haloperidol, versus placebo in patients with schizophrenia and schizoaffective
disorder. J Clin Psychiatry 2002; 63:763-771.

Lawyer CP, Prioleay C, Lewis MM et al .Interactions of the novel antipsychotic

aripiprazole (OPC-14597) with dopamine and serotonin receptor subtypes.
Neuropsychopharmacolcogy 1999; 20 (6): 612 – 627.

Marder SR, McQuade RD, Stock E, et al. Aripiprazole in the treatment of

schizophrenia: safety and tolerability in short-term, placebo controlled trials.
Schizophrenia Research 2003; 61:123-136.

Rivas-Vasquez RA. Aripiprazole: A novel antipsychotic with dopamine stabilizing

properties. Professional Psychology: Research and Practice 2003; 34(1):108-11.