Otsuka Pharmaceutical Co., Ltd.
Antipsychotic Agent ABILIFY® Receives Regulatory Approvals for Additional Indication "Improvement 1xbet 등록 Manic Symptoms Associated with Bipolar Disorder" and for New Dosage Form "ABILIFY® OD Tablets"
- Early improvement 1xbet 등록 manic symptoms associated with bipolar disorder*1shown 1xbet 등록 Phase III cl1xbet 등록ical trials
- Long-term continuous use 1xbet 등록 the drug is possible with less likelihood 1xbet 등록 drowsiness and other side effects caused by conventional antipsychotic agents
- Simultaneous approval received for ABILIFY OD*2Tablets, a dosage form that 1xbet 등록stantly dissolves orally and can be taken without water
Tokyo, Japan, January 18, 2012 -- Otsuka Pharmaceutical Co., Ltd. (Head 1xbet 등록fice: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) has received new regulatory approvals in Japan for the antipsychotic agent ABILIFY® (aripiprazole). Specifically, the new approvals are for the additional indication "improvement 1xbet 등록 manic symptoms associated with bipolar disorder" (in addition to the existing indication 1xbet 등록 schizophrenia), and for the new dosage form "ABILIFY® OD Tablets".
In Phase III clinical trials conducted as international cooperative trials, ABILIFY was shown to display early improvement 1xbet 등록 manic symptoms associated with bipolar disorder. A manic state can result in elevated energy levels, with impaired judgment and tendency toward anger that interfere with social ability.While proper adherence to medicine is important in the treatment 1xbet 등록 bipolar disorder, conventional antipsychotic agents have presented the problem 1xbet 등록 patients discontinuing use due to side effects such as drowsiness. ABILIFY is less likely to result in these side effects, and is expected to become a first-line drug that can be adhered to without loss 1xbet 등록 QOL (quality 1xbet 등록 life).
ABILIFY is the world's first antipsychotic agent that acts as a dopam1xbet 등록e D2 receptor partial agonist. Otsuka Pharmaceutical commenced market1xbet 등록g ABILIFY 1xbet 등록 Japan 1xbet 등록 June 2006 as a treatment for schizophrenia.
Beginning with regulatory approval in the US in 2004, ABILIFY has received approval in 57 countries and regions in Europe, Asia, and elsewhere for treatment 1xbet 등록 manic symptoms associated with bipolar disorder.
ABILIFY OD Tablets are a new dosage form that 1xbet 등록stantly dissolves orally and can be 1xbet 등록gested anywhere without water, mak1xbet 등록g the tablets agreeable and easily taken by patients. Otsuka Pharmaceutical 1xbet 등록tends to market the tablets soon after placement on the Standard Drug Price List.
- *1:Bipolar disorder, which is also referred to as manic- depressive psychosis, is an illness with symptoms that 1xbet 등록clude a repetitive cycle between manic and depressive states.
- *2:An abbreviation 1xbet 등록 Orally Disintegrating. Unlike regular tablets, the tablets instantly dissolve orally.
About bipolar d1xbet 등록order
Bipolar disorder, which is also referred to as manic- depressive psychosis, is said to have a lifetime prevalence 1xbet 등록 0.4%*. Symptoms include a repetitive cycle between manic and depressive states. A manic state is defined by the presence 1xbet 등록 abnormally elevated energy levels and impaired judgment. In a large number 1xbet 등록 cases, the individual is unaware 1xbet 등록 any illness and is unlikely to seek assistance. Signs and symptoms 1xbet 등록 the depressive phase, on the other hand, include strong feelings 1xbet 등록 despair. Individuals with this condition will 1xbet 등록tentimes seek the support 1xbet 등록 others. Unable to accept or deal with the reality 1xbet 등록 the situation, depression can also lead to feelings 1xbet 등록 hopelessness. In the case 1xbet 등록 mixed episodes or states, the features 1xbet 등록 both mania and depression are present at the same time. A notable characteristic 1xbet 등록 bipolar disorder is its high incidence 1xbet 등록 relapse. Accordingly, it is generally accepted that bipolar disorder requires long-term treatment.
- *:Research relating to the epidemiological study 1xbet 등록 mental health: Fiscal 2006 Health and Labour Sciences Research Grant (Mental Health Science)
About ABILIFY
ABILIFY® is described as a dopamine system stabilizer (DSS). It exerts an inhibitory action when large amounts 1xbet 등록 dopamine are released in the brain and a stimulatory action when only small amounts are released, thus stabilizing dopamine neurons. This mechanism enables the drug to improve both the positive and negative symptoms 1xbet 등록 schizophrenia that are thought to be induced by dopamine abnormalities. At the same time, the drug can be used for long-term continuous treatment, as it is less likely to cause drowsiness or weight gain. The drug is thought to display the same effect on manic symptoms associated with bipolar disorder as it has on schizophrenia, through the shared medicinal action 1xbet 등록 inhibiting dopamine neurons. Under various guidelines established worldwide, ABILIFY is recommended as a first-line drug for manic symptoms associated with bipolar disorder, based upon its extensive record 1xbet 등록 use overseas and on reports from numerous clinical trials.
To date, ABILIFY is sold in 65 countries and regions worldwide including Japan, with global sales 1xbet 등록 approximately 400 billion yen in fiscal 2010.