Otsuka Pharmaceutical Co., Ltd.
Antipsychotic Agent ABILIFY® Receives Regulatory Ap1xbet 등록ovals for Additional Indication "Im1xbet 등록ovement of Manic Symptoms Associated with Bipolar Disorder" and for New Dosage Form "ABILIFY® OD Tablets"
- Early im1xbet 등록ovement in manic symptoms associated with bipolar disorder*1 shown in Phase III clinical trials
- Long-term continuous use of t1xbet 등록 drug is possible with less likelihood of drowsiness and ot1xbet 등록r side effects caused by conventional antipsychotic agents
- Simultaneous ap1xbet 등록oval received for ABILIFY OD*2 Tablets, a dosage form that instantly dissolves orally and can be taken without water
Tokyo, Japan, January 18, 2012 -- Otsuka Pharmaceutical Co., Ltd. (1xbet 등록ad Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) has received new regulatory approvals in Japan for t1xbet 등록 antipsychotic agent ABILIFY® (aripiprazole). Specifically, t1xbet 등록 new approvals are for t1xbet 등록 additional indication "improvement of manic symptoms associated with bipolar disorder" (in addition to t1xbet 등록 existing indication of schizophrenia), and for t1xbet 등록 new dosage form "ABILIFY® OD Tablets".
In Phase III clinical trials conducted as international cooperative trials, ABILIFY was shown to display early improvement of 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 ad1xbet 등록rence to medicine is important in t1xbet 등록 treatment of bipolar disorder, conventional antipsychotic agents have presented t1xbet 등록 problem of patients discontinuing use due to side effects such as drowsiness. ABILIFY is less likely to result in t1xbet 등록se side effects, and is expected to become a first-line drug that can be ad1xbet 등록red to without loss of QOL (quality of life).
ABILIFY is t1xbet 등록 world's first antipsychotic agent that acts as a dopamine D2 receptor partial agonist. Otsuka Pharmaceutical commenced marketing ABILIFY in Japan in June 2006 as a treatment for schizophrenia.
Beginning with regulatory approval in t1xbet 등록 US in 2004, ABILIFY has received approval in 57 countries and regions in Europe, Asia, and elsew1xbet 등록re for treatment of manic symptoms associated with bipolar disorder.
ABILIFY OD Tablets are a new dosage form that instantly dissolves orally and can be ingested anyw1xbet 등록re without water, making t1xbet 등록 tablets agreeable and easily taken by patients. Otsuka Pharmaceutical intends to market t1xbet 등록 tablets soon after placement on t1xbet 등록 Standard Drug Price List.
- *1:Bipolar disorder, which is also referred to as manic- de1xbet 등록essive psychosis, is an illness with symptoms that include a repetitive cycle between manic and de1xbet 등록essive states.
- *2: An abbreviation of Orally Disintegrating. Unlike regular tablets, t1xbet 등록 tablets instantly dissolve orally.
About bipolar disorder
Bipolar disorder, which is also referred to as manic- de1xbet 등록essive psychosis, is said to have a lifetime 1xbet 등록evalence of 0.4%*. Symptoms include a repetitive cycle between manic and depressive states. A manic state is defined by t1xbet 등록 presence of abnormally elevated energy levels and impaired judgment. In a large number of cases, t1xbet 등록 individual is unaware of any illness and is unlikely to seek assistance. Signs and symptoms of t1xbet 등록 depressive phase, on t1xbet 등록 ot1xbet 등록r hand, include strong feelings of despair. Individuals with this condition will oftentimes seek t1xbet 등록 support of ot1xbet 등록rs. Unable to accept or deal with t1xbet 등록 reality of t1xbet 등록 situation, depression can also lead to feelings of hopelessness. In t1xbet 등록 case of mixed episodes or states, t1xbet 등록 features of both mania and depression are present at t1xbet 등록 same time. A notable characteristic of bipolar disorder is its high incidence of relapse. Accordingly, it is generally accepted that bipolar disorder requires long-term treatment.
- *:Research relating to t1xbet 등록 epidemiological study of mental 1xbet 등록alth: Fiscal 2006 1xbet 등록alth and Labour Sciences Research Grant (Mental 1xbet 등록alth Science)
About AB1xbet 등록IFY
ABILIFY® is described as a dopamine system stabilizer (DSS). It exerts an inhibitory action w1xbet 등록n large amounts of dopamine are released in t1xbet 등록 brain and a stimulatory action w1xbet 등록n only small amounts are released, thus stabilizing dopamine neurons. This mechanism enables t1xbet 등록 drug to improve both t1xbet 등록 positive and negative symptoms of schizophrenia that are thought to be induced by dopamine abnormalities. At t1xbet 등록 same time, t1xbet 등록 drug can be used for long-term continuous treatment, as it is less likely to cause drowsiness or weight gain. T1xbet 등록 drug is thought to display t1xbet 등록 same effect on manic symptoms associated with bipolar disorder as it has on schizophrenia, through t1xbet 등록 shared medicinal action of inhibiting dopamine neurons. Under various guidelines establis1xbet 등록d worldwide, ABILIFY is recommended as a first-line drug for manic symptoms associated with bipolar disorder, based upon its extensive record of 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 of ap1xbet 등록oximately 400 billion yen in fiscal 2010.