What is Aripiprazole Accord and what is it used for?
Aripiprazole Accord is used in patients with the following mental illnesses:
- schizophrenia, a mental illness characterized by a series of symptoms, including disorders of thought and language, hallucinations (seeing or hearing non-existent things), suspiciousness and fixations (false convictions). Aripiprazole Accord is used in patients aged 15 years or older;
- bipolar I disorder, a mental illness in which patients suffer manic episodes (periods of abnormal euphoric state), alternating with periods of normal mood, and may also have episodes of depression. Aripiprazole Accord is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past. Aripiprazole Accord is also used for up to 12 weeks for the treatment of moderate to severe manic episodes in patients from the age of 13 years.
Aripiprazole Accord contains the active substance aripiprazole and is a "generic medicine". This means that Aripiprazole Accord is similar to a "reference medicine" already authorized in the European Union (EU) called Abilify. For more information on generic medicines, see the questions and answers by clicking here.
How is Aripiprazole Accord used?
Aripiprazole Accord is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
For schizophrenia, the recommended starting dose is 10 or 15 mg orally once a day 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 (using a liquid-based medicine of aripiprazole), which is gradually increased to the recommended dose of 10 mg once a day .
For the treatment of manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg orally once a day, either as monotherapy or in combination with other medicines. For the prevention of manic episodes in adults it is appropriate to continue with the same dose.
For the treatment of manic episodes in patients aged 13 to 17 years, the starting dose is 2 mg a day (using a liquid-based medicine of aripiprazole), which is gradually increased to the recommended dose of 10 mg once a day. The treatment should not last more than 12 weeks.
The dose should be adjusted in subjects taking other medicines that influence the absorption of Aripiprazole Accord in the body. For more information, see the summary of product characteristics (included with EPAR).
How does Aripiprazole Accord work?
The active substance in Aripiprazole Accord, aripiprazole, is an antipsychotic medicine. Although its exact mechanism of action is not known, it nevertheless binds to some receptors on the surface of nerve cells in the brain. In this way it disturbs the signals transmitted between brain cells by "neurotransmitters", chemicals that allow communication between nerve cells. Aripiprazole is believed to act essentially as a "partial agonist" of dopamine and 5-hydroxytryptamine neurotransmitter receptors (also called serotonin). That is, it acts as dopamine and 5- hydroxytryptamine, activating these receptors but less strongly than neurotransmitters. Since dopamine and 5-hydroxytryptamine are implicated in schizophrenia and bipolar disorder, aripiprazole contributes to the normalization of brain activity, reducing psychotic or manic symptoms and preventing its reappearance.
How has Aripiprazole Accord been studied?
Because Aripiprazole Accord is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Abilify. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Aripiprazole Accord?
Because Aripiprazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Aripiprazole Accord been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Accord has been shown to have comparable quality and to be bioequivalent to Abilify. Therefore, the CHMP considered that, as in the case of Abilify, the benefits outweigh the identified risks and recommended to approve the use of Aripiprazole Accord in the EU.
What measures are being taken to ensure the safe and effective use of Aripiprazole Accord?
A risk management plan has been developed to ensure that Aripiprazole Accord is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information is available in the summary of the risk management plan.
In addition, the company that markets Aripiprazole Accord will provide information material to patients or healthcare professionals as well as physicians to explain the safe use of the medicine in patients aged 13 to 17 years.
More information on Aripiprazole Accord
For more information about treatment with Aripiprazole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website.
