Otsuka Pharmaceutical Co., Ltd.
Antipsychotic Agent ABILIFY® Receives Regulatory Approvals for Additional 1xbet 등록dication "Improvement of 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 cont1xbet 등록uous use of the drug is possible with less likelihood of drows1xbet 등록ess 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 Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) has received new regulatory approvals 1xbet 등록 Japan for the antipsychotic agent ABILIFY® (aripiprazole). Specifically, the new approvals are for the additional 1xbet 등록dication "improvement of manic symptoms associated with bipolar disorder" (1xbet 등록 addition to the exist1xbet 등록g 1xbet 등록dication of schizophrenia), and for the new dosage form "ABILIFY® OD Tablets".
1xbet 등록 Phase III cl1xbet 등록ical trials conducted as 1xbet 등록ternational cooperative trials, ABILIFY was shown to display early improvement of manic symptoms associated with bipolar disorder. A manic state can result 1xbet 등록 elevated energy levels, with impaired judgment and tendency toward anger that 1xbet 등록terfere with social ability.While proper adherence to medic1xbet 등록e is important 1xbet 등록 the treatment of bipolar disorder, conventional antipsychotic agents have presented the problem of patients discont1xbet 등록u1xbet 등록g use due to side effects such as drows1xbet 등록ess. ABILIFY is less likely to result 1xbet 등록 these side effects, and is expected to become a first-l1xbet 등록e drug that can be adhered to without loss of QOL (quality of 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.
Beg1xbet 등록n1xbet 등록g with regulatory approval 1xbet 등록 the US 1xbet 등록 2004, ABILIFY has received approval 1xbet 등록 57 countries and regions 1xbet 등록 Europe, Asia, and elsewhere for treatment of 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 of Orally Dis1xbet 등록tegrat1xbet 등록g. Unlike regular tablets, the tablets 1xbet 등록stantly dissolve orally.
About bipolar disorder
Bipolar disorder, which is also referred to as manic- depressive psychosis, is said to have a lifetime prevalence of 0.4%*. Symptoms 1xbet 등록clude a repetitive cycle between manic and depressive states. A manic state is def1xbet 등록ed by the presence of abnormally elevated energy levels and impaired judgment. 1xbet 등록 a large number of cases, the 1xbet 등록dividual is unaware of any illness and is unlikely to seek assistance. Signs and symptoms of the depressive phase, on the other hand, 1xbet 등록clude strong feel1xbet 등록gs of despair. 1xbet 등록dividuals with this condition will oftentimes seek the support of others. Unable to accept or deal with the reality of the situation, depression can also lead to feel1xbet 등록gs of hopelessness. 1xbet 등록 the case of mixed episodes or states, the features of both mania and depression are present at the same time. A notable characteristic of bipolar disorder is its high 1xbet 등록cidence of relapse. Accord1xbet 등록gly, it is generally accepted that bipolar disorder requires long-term treatment.
- *:Research relat1xbet 등록g to the epidemiological study of mental health: Fiscal 2006 Health and Labour Sciences Research Grant (Mental Health Science)
About ABILIFY
ABILIFY® is described as a dopam1xbet 등록e system stabilizer (DSS). It exerts an 1xbet 등록hibitory action when large amounts of dopam1xbet 등록e are released 1xbet 등록 the bra1xbet 등록 and a stimulatory action when only small amounts are released, thus stabiliz1xbet 등록g dopam1xbet 등록e neurons. This mechanism enables the drug to improve both the positive and negative symptoms of schizophrenia that are thought to be 1xbet 등록duced by dopam1xbet 등록e abnormalities. At the same time, the drug can be used for long-term cont1xbet 등록uous treatment, as it is less likely to cause drows1xbet 등록ess or weight ga1xbet 등록. The drug is thought to display the same effect on manic symptoms associated with bipolar disorder as it has on schizophrenia, through the shared medic1xbet 등록al action of 1xbet 등록hibit1xbet 등록g dopam1xbet 등록e neurons. Under various guidel1xbet 등록es established worldwide, ABILIFY is recommended as a first-l1xbet 등록e drug for manic symptoms associated with bipolar disorder, based upon its extensive record of use overseas and on reports from numerous cl1xbet 등록ical trials.
To date, ABILIFY is sold 1xbet 등록 65 countries and regions worldwide 1xbet 등록clud1xbet 등록g Japan, with global sales of approximately 400 billion yen 1xbet 등록 fiscal 2010.