What is Abilify?
Abilify is a medicine that contains the active substance aripiprazole. It is available as tablets (blue rectangular: 5 mg; pink rectangular: 10 mg; yellow round: 15 mg; pink round: 30 mg), in orodispersible round tablets (which dissolve in the mouth; pink : 10 and 30 mg; yellow: 15 mg), in an oral solution (1 mg / ml) and in a solution for injection (7.5 mg / ml).
What is Abilify used for?
Abilify is indicated in patients suffering from the following mental pathologies:
- schizophrenia, a mental illness characterized by a series of symptoms, including thought and speech disorders, hallucinations (hearing or seeing things that do not exist), suspiciousness and delusions (mistaken beliefs). Abilify is used to treat patients aged 15 or over;
- bipolar type I disorder, a mental illness in which patients experience manic episodes (periods of abnormal euphoria) alternating with periods of normal mood. Depression may also occur. Abilify is used for the treatment of moderate to severe manic episodes and for the prevention of manic episodes in patients who have responded to the medicine in the past. Abilify is used in adults (aged 18 or over).
The solution for injection is used for rapid control of agitated or disturbed behavior in adults, where oral dose is not recommended.
The medicine can only be obtained with a prescription.
How is Abilify used?
In case of schizophrenia, the recommended starting dose is 10 or 15 mg per day orally in adults, followed by a maintenance dose of 15 mg once a day. In patients aged 15 to 17 years, the starting dose is 2 mg a day, and is gradually increased to the recommended dose of 10 mg once a day. For bipolar disorder, the recommended starting dose is 15 mg once a day taken orally, taken singly or in combination with other medicines. To prevent manic episodes, the same dose should be maintained. For both diseases, some patients may benefit from a higher dose.
Oral solution or orodispersible tablets can be used in patients with difficulty swallowing tablets. The orodispersible tablets are taken by placing them on the tongue,
where they dissolve rapidly on contact with saliva, or diluted in water before consumption. The solution for injection is intended for short-term use in adults only and should be replaced with tablets, orodispersible tablets or oral solution as soon as possible: the usual dose is 9.75 mg in a single injection into the muscle of the shoulder or buttock, but effective doses range from 5.25 mg to 15 mg. It is possible to administer a second injection starting from two hours after the first, where necessary, up to a maximum recommended of three injections over the 24 hours.
The medicine can be given with or without food. The daily dose should not exceed 30 mg. The dose of Abilify should be adjusted if patients take other medicines that are metabolised in a similar way. For more information, see the package leaflet.
How does Abilify work?
The active substance in Abilify, aripiprazole, is an antipsychotic drug. Although the precise mechanism of action is not known, it is thought that this substance binds to a series of receptors present on the surface of the nerve cells of the brain. This interrupts the signals transmitted between brain cells by "neurotransmitters", ie chemical substances that allow to nerve cells to communicate with each other. Aripiprazole is believed to act primarily as a "partial agonist" for receptors of dopamine and 5-hydroxytryptamine neurotransmitters (also known as serotonin). This means that aripiprazole acts like dopamine and 5-hydroxytryptamine activating these receptors, but less strongly than neurotransmitters. Since 5-hydroxytryptamine and dopamine are implicated in schizophrenia and bipolar disorder, aripiprazole contributes to the normalization of brain activity, reducing psychotic or manic symptoms and preventing its reappearance.
What studies have been carried out on Abilify?
For the treatment of schizophrenia, three main short-term studies of four to six weeks were conducted, involving 1 203 adults, in which Abilify tablets were compared to a placebo (a dummy treatment). The effectiveness of Abilify in preventing symptom recurrence was examined in three studies lasting up to a year. In two of these studies the comparator medicine used was haloperidol (another antipsychotic drug). Abilify tablets were also compared with placebo in a study involving 302 patients aged 13 to 17 years. The solution for injection was compared with placebo over a period of two hours, in two studies involving 805 schizophrenic adults or those with related conditions, in a state of agitation. In all the studies the change in the patient's symptoms was measured based on a standard scale of evaluation of schizophrenia.
For the treatment of bipolar disorder, eight main studies were conducted on Abilify taken orally. Five of these studies compared Abilify with a placebo over a period of three weeks out of a total of 1 900 patients and two of these studies were continued for another nine weeks to study the maintenance of the effect, using haloperidol and lithium ( other antipsychotic drug) as comparators. The sixth study compared Abilify with haloperidol over a 12-week period of 347 patients, and the seventh study compared Abilify with a placebo in preventing relapse in 160 patients whose manic symptoms had already been stabilized with Abilify. The eighth study examined the effect of adding Abilify or a placebo to existing treatment with lithium or valproate (another antipsychotic drug) on 384 patients. Abilify in solution for injection was compared with lorazepam (another antipsychotic drug) and with placebo, over a two-hour period, in a study involving 301 patients with symptoms of agitation. In all of the studies the change in the patient's symptoms was taken into consideration based on a standard scale of assessment of bipolar disorder or the number of patients who responded to treatment.
The company has also conducted studies to verify the absorption of the orodispersible tablets and the oral solution by the body.
What benefit has Abilify shown during the studies?
Abilify was more effective than placebo at improving schizophrenia symptoms in short-term studies. In long-term studies, the medicine was more effective than placebo and as effective as haloperidol, after no more than a year of treatment. Abilify was also more effective than placebo for six weeks in the adolescent study and the effect was maintained for more than six months in patients over the age of 15 years. In both studies with injection solution, subjects who received Abilify showed a significantly greater reduction in agitation symptoms than patients treated with placebo.
When used for the treatment of bipolar disorder, Abilify was more effective than placebo in reducing manic symptoms in four out of five of the short-term studies. The medicine has also reported effects similar to haloperidol and lithium over three weeks. The effect lasted for up to 12 weeks. Abilify was also more effective than placebo in preventing the recurrence of manic episodes in patients previously treated for up to 74 weeks and as an adjunctive treatment to another ongoing treatment. Abilify injections were also more effective than placebo in reducing agitation symptoms and efficaciously similar to lorazepam.
What is the risk associated with Abilify?
In adults the most common side effects from taking Abilify orally (seen in between 1 and 10 patients in 100) are restlessness, insomnia (difficulty sleeping), anxiety, extrapyramidal disorder (convulsions or uncontrolled spasms), akathisia (inability to stand still ), tremor, dizziness, drowsiness, sedation, headache, blurred vision, dyspepsia (heartburn), vomiting, nausea, constipation, salivary hypersecretion (increase in saliva production) and fatigue. Akathisia is more frequent in patients with bipolar disorder than in schizophrenic patients. Side effects are similar in adolescents, but sleepiness, sedation and extrapyramidal disorders are more common than in adults. The most common side effects with the injection (seen in between 1 and 10 patients in 100) are drowsiness, dizziness, headache, akathisia, nausea and vomiting. For the full list of all side effects reported with Abilify, see the Package Leaflet.
Abilify should not be used in people who may be hypersensitive (allergic) to aripiprazole or any of the other components.
Why has Abilify been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Abilify's benefits are greater than its risks for the treatment of schizophrenia in adults and adolescents aged 15 and above and manic to moderate to severe episodes of bipolar I disorder as well as for the prevention of a new manic episode in patients who have experienced manic predominant episodes and responded to treatment with aripiprazole. The Committee also decided that the benefits of the injectable solution outweigh the risks for rapid control of agitation and behavioral disorders in patients with schizophrenia or in patients with manic episodes in the context of bipolar I disorder, where oral therapy is not indicated. The committee therefore recommended the granting of the marketing authorization for Abilify.
More information on Abilify:
On 4 June 2004, the European Commission granted a marketing authorization for Abilify, valid throughout the European Union, to Otsuka Pharmaceutical Europe Ltd. The marketing authorization was renewed on 4 June 2009.
Last update of this summary: 09-2009
