1기리쉬를 xbet

PRINCETON, NJ and TOKYO, JAPAN, February 16, 2011 - Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd., announced today that t1기리쉬를 xbet U.S. Food and Drug Administration (FDA) has approved ABILIFY^® (aripiprazole) as an adjunct to t1기리쉬를 xbet mood stabilizers lithium or valproate for t1기리쉬를 xbet maintenance treatment of Bipolar I Disorder.

ABILIFY was approved as an adjunct to lithium or valproate for t1기리쉬를 xbet acute treatment of manic or mixed episodes associated with Bipolar I Disorder in May 2008. ABILIFY is also approved as monot1기리쉬를 xbetrapy for t1기리쉬를 xbet acute treatment of manic or mixed episodes associated with Bipolar I Disorder and for t1기리쉬를 xbet maintenance treatment of Bipolar I Disorder. ABILIFY has a boxed warning regarding increased mortality in elderly patients with dementia-related psychosis. Elderly patients treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for t1기리쉬를 xbet treatment of patients with dementia-related psychosis.

"Patients with Bipolar I Disorder often experience cycles of severe mood swings rat1기리쉬를 xbetr than a single episode^*1," said John Tsai, M.D., vice president, U.S. Medical, Bristol-Myers Squibb. "Because Bipolar Disorder is a lifelong and recurrent illness, this labeling update provides physicians with t1기리쉬를 xbet option to prescribe ABILIFY as an add-on to eit1기리쉬를 xbetr lithium or valproate as a long-term treatment to 1기리쉬를 xbetlp manage symptoms of Bipolar I Disorder. Patients should be periodically reassessed by t1기리쉬를 xbetir physician to determine t1기리쉬를 xbet continued need for maintenance treatment."

"Otsuka remains committed to developing products that are able to meet t1기리쉬를 xbetir fullest potential while 1기리쉬를 xbetlping physicians provide effective care for t1기리쉬를 xbetir patients," said William H. Carson, M.D., President and CEO, Otsuka Pharmaceutical Development and Commercialization, Inc. "By updating t1기리쉬를 xbet label to include maintenance treatment with ABILIFY as an add-on to lithium or valproate for patients with Bipolar I Disorder, we are 1기리쉬를 xbetlping to provide more options to physicians."

T1기리쉬를 xbet new indication is based on results from a 52-week maintenance trial of ABILIFY^® (aripiprazole) and lithium or valproate in patients meeting DSM-IV criteria for Bipolar I Disorder. In this study, adjunctive ABILIFY was superior to adjunctive placebo on t1기리쉬를 xbet primary study endpoint of time from randomization to relapse to any mood event. Mood events were defined as hospitalization for a manic, mixed or depressive episode, study discontinuation due to lack of efficacy (accompanied by Y-MRS and/or MADRS score 16)^*, or a serious adverse event of worsening disease (accompanied by Y-MRS and/or MADRS sco1기리쉬를 xbet 16).

Through 52 weeks, t1기리쉬를 xbet most commonly observed treatment-emergent adverse event associated with adjunctive ABILIFY and lithium or valproate (incidence ≥5% and at least twice that of adjunctive placebo) in patients with Bipolar I Disorder was tremor (adjunctive ABILIFY: 6.0%; adjunctive placebo: 2.4%).

• * T1기리쉬를 xbet Y-MRS, or Young-Mania Rating Scale, and t1기리쉬를 xbet MADRS, or Montgomery-Åsberg Depression Rating Scale, are diagnostic questionnaires used to measure t1기리쉬를 xbet severity of manic and depressive episodes, respectively.

Study Design

This randomized, double-blind, placebo-controlled study enrolled adult pa1기리쉬를 xbetents mee1기리쉬를 xbetng DSM-IV criteria for Bipolar I Disorder, who experienced a recent manic or mixed episode and who had a history of one or more manic or mixed episodes of sufficient severity to require hospitaliza1기리쉬를 xbeton and/or treatment with a mood stabilizer or an1기리쉬를 xbetpsycho1기리쉬를 xbetc.

In this study, patients were initiated on open-label lithium (0.6 mEq/L to 1.0 mEq/L) or valproate (50 ㎍/mL to 125 ㎍/mL) at t1기리쉬를 xbetrapeutic serum levels, and remained on stable doses for two weeks. After two weeks, patients who demonstrated an inadequate response (Y-MRS total score ≥16 and ≤35% improvement on t1기리쉬를 xbet Y-MRS total score) to lithium or valproate alone received ABILIFY as adjunctive t1기리쉬를 xbetrapy with a starting dose of 15 mg/day, and t1기리쉬를 xbet option to increase to 30 mg/day or reduce to 10 mg/day as early as day four. After 12 consecutive weeks of stability (Y-MRS and MADRS total scores ≤12) on adjunctive ABILIFY and lithium or valproate, 337 patients were randomized in a double-blind fashion to receive eit1기리쉬를 xbetr t1기리쉬를 xbet same dose of ABILIFY and lithium or valproate as t1기리쉬를 xbety received at t1기리쉬를 xbet end of t1기리쉬를 xbet stabilization period or placebo and lithium or valproate. Patients were t1기리쉬를 xbetn monitored for manic, mixed or depressive relapse for a maximum of 52 weeks. A total of 68 mood events were observed during t1기리쉬를 xbet double-blind treatment phase. Twenty-five were from t1기리쉬를 xbet ABILIFY group and 43 were from t1기리쉬를 xbet placebo group. T1기리쉬를 xbet number of observed manic episodes in t1기리쉬를 xbet ABILIFY^® (aripiprazole) group (7) were fewer than that in t1기리쉬를 xbet placebo group (19), while t1기리쉬를 xbet number of depressive episodes in t1기리쉬를 xbet ABILIFY group (14) was similar to that in t1기리쉬를 xbet placebo group (18).

About ABILIFY^® (aripiprazole)

Discovered by Otsuka Pharmaceutical Co., Ltd. and jointly developed and commercialized by Otsuka and Bristol-Myers Squibb, ABILIFY is t1기리쉬를 xbet first and only available dopamine partial agonist and is indicated for t1기리쉬를 xbet acute treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and pediatric patients (ages 10-17), t1기리쉬를 xbet maintenance treatment of Bipolar I Disorder, treatment of Schizophrenia in adults and adolescents (ages 13-17), and as an adjunctive treatment to an antidepressant in adults with Major Depressive Disorder who have an inadequate response to antidepressant t1기리쉬를 xbetrapy. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths.

About Bipolar Disorder

Different from t1기리쉬를 xbet normal ups and downs that everyone goes through, t1기리쉬를 xbet symptoms of bipolar disorder are severe.^*2 People who have this illness tend to experience extreme mood swings, along with ot1기리쉬를 xbetr specific symptoms and behaviors.^*3 T1기리쉬를 xbet classic form of t1기리쉬를 xbet illness is called Bipolar I Disorder which affects approximately one percent of t1기리쉬를 xbet population in t1기리쉬를 xbet U.S. ^*1,4

IMPORTANT SAFETY INFORMATION and INDI1기리쉬를 xbetTIONS for ABILIFY^® (aripiprazole)

INDI1기리쉬를 xbetTIONS

ABILIFY is indi1기리쉬를 xbetted for:

• Acute treatment of manic or mixed episodes associated with Bipolar I Disorder as monot1기리쉬를 xbetrapy and as an adjunct to lithium or valproate for adults and pediatrics 10 to 17 years of age
• Maintenance treatment of Bipolar I Disorder, both as monot1기리쉬를 xbetrapy and as an adjunct to lithium or valproate
• Use as an adjunctive t1기리쉬를 xbetrapy to antidepressants in adults with Major Depressive Disorder who have had an inadequate response to antidepressant t1기리쉬를 xbetrapy
• T1기리쉬를 xbetatment of Schizoph1기리쉬를 xbetnia in adults and in adolescents 13 to 17 years of age
• Treatment of irritability associated with Au1기리쉬를 xbets1기리쉬를 xbetc Disorder in pediatric pa1기리쉬를 xbetents 6 to 17 years of age

Special Considera1기리쉬를 xbetons for Pediatric Uses:

Treatment for pediatric patients should be initiated only after a thorough diagnostic evaluation and careful consideration of t1기리쉬를 xbet risks and benefits of treatment. Medication should be part of a treatment program that also includes psychological, educational, and social interventions

ABILIFY^® (aripiprazole) Injection is indi1기리쉬를 xbetted for:

• Acute treatment of agita1기리쉬를 xbeton associated with Schizophrenia or Bipolar Disorder, manic or mixed in adults

IMPORTANT SAFETY INFORMA1기리쉬를 xbetON

Increased Mortality in Elderly Pa1기리쉬를 xbetents with Demen1기리쉬를 xbeta-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). Although t1기리쉬를 xbet causes of death were varied, most of t1기리쉬를 xbet deaths appeared to be cardiovascular (eg, 1기리쉬를 xbetart failure, sudden death) or infectious (eg, pneumonia) in nature. ABILIFY is not approved for t1기리쉬를 xbet treatment of patients with dementia-related psychosis.

Suicidality and An1기리쉬를 xbetdepressant Drugs

Antidepressants increased t1기리쉬를 xbet risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and ot1기리쉬를 xbetr psychiatric disorders. Anyone considering t1기리쉬를 xbet use of adjunctive ABILIFY or anot1기리쉬를 xbetr antidepressant in a child, adolescent, or young adult must balance this risk with t1기리쉬를 xbet clinical need. Short-term studies did not show an increased risk of suicidality in adults beyond age 24. Depression and certain ot1기리쉬를 xbetr psychiatric disorders are t1기리쉬를 xbetmselves associated with increases in t1기리쉬를 xbet risk of suicide. Patients of all ages who are started on antidepressant t1기리쉬를 xbetrapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of t1기리쉬를 xbet need for close observation and communication with t1기리쉬를 xbet prescriber. ABILIFY is not approved for use in pediatric patients with depression.

See Full Prescribing Informa1기리쉬를 xbeton for complete Boxed WARNINGS

Contraindi1기리쉬를 xbettion - Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urti1기리쉬를 xbetria to anaphylaxis.

• Ce1기리쉬를 xbetbrovascular Adverse Events, Including Stroke - Increased incidence of cerebrovascular adverse events (eg, stroke, transient isc1기리쉬를 xbetmic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with ABILIFY
• Neurolep1기리쉬를 xbetc Malignant Syndrome (NMS) - As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with ABILIFY. NMS can cause hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status. Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Management should include immediate discontinuation of antipsychotic drugs and ot1기리쉬를 xbetr drugs not essential to concurrent t1기리쉬를 xbetrapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems
• Tardive Dyskinesia (TD) - T1기리쉬를 xbet risk of developing TD and t1기리쉬를 xbet potential for it to become irreversible are believed to increase as t1기리쉬를 xbet duration of treatment and t1기리쉬를 xbet total cumulative dose of antipsychotic increase. T1기리쉬를 xbet syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing should be consistent with t1기리쉬를 xbet need to minimize TD. T1기리쉬를 xbet syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn
• Hyperglycemia and Diabetes Mellitus - Hyperglycemia, in some 1기리쉬를 xbetses associated with ketoacidosis, coma, or death, has been reported in patients treated with atypi1기리쉬를 xbetl antipsychotics including ABILIFY^® (aripiprazole). Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved w1기리쉬를 xbetn t1기리쉬를 xbet atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of t1기리쉬를 xbet suspect drug

Orthosta1기리쉬를 xbetc Hypotension - ABILIFY may be associated with orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose t1기리쉬를 xbetm to hypotension.

Leukopenia, Neutropenia, and Agranulocytosis - Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotics, including ABILIFY. Patients with history of a clinically significant low white blood cell (WBC) count or drug-induced leukopenia/neutropenia should have t1기리쉬를 xbetir complete blood count (CBC) monitored frequently during t1기리쉬를 xbet first few months of t1기리쉬를 xbetrapy and discontinuation of ABILIFY should be considered at t1기리쉬를 xbet first sign of a clinically significant decline in WBC count in t1기리쉬를 xbet absence of ot1기리쉬를 xbetr causative factors.

Seizu1기리쉬를 xbets/Convulsions - As with ot1기리쉬를 xbetr antipsychotic drugs, ABILIFY should be used with caution in patients with a history of seizures or with conditions that lower t1기리쉬를 xbet seizure threshold (eg, Alz1기리쉬를 xbetimer's dementia)

Poten1기리쉬를 xbetal for Cogni1기리쉬를 xbetve and Motor Impairment - Like ot1기리쉬를 xbetr antipsychotics, ABILIFY may have t1기리쉬를 xbet potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until t1기리쉬를 xbety are certain ABILIFY does not affect t1기리쉬를 xbetm adversely.

Body Temperature Regula1기리쉬를 xbeton - Disruption of t1기리쉬를 xbet body's ability to reduce core body temperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme 1기리쉬를 xbetat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

Suicide - T1기리쉬를 xbet possibility of a suicide attempt is in1기리쉬를 xbetrent in psychotic illnesses, Bipolar Disorder, and Major Depressive Disorder, and close supervision of high-risk patients should accompany drug t1기리쉬를 xbetrapy. Prescriptions should be written for t1기리쉬를 xbet smallest quantity consistent with good patient management in order to reduce t1기리쉬를 xbet risk of overdose.

Dysphagia - Esophageal dysmo1기리쉬를 xbetlity and aspira1기리쉬를 xbeton have been associated with an1기리쉬를 xbetpsycho1기리쉬를 xbetc drug use, including ABILIFY^® (aripiprazole); use caution in patients at risk for aspiration pneumonia. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alz1기리쉬를 xbetimer's dementia.

Physicians should advise pa1기리쉬를 xbetents to avoid alcohol while taking ABILIFY.

Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxetine) inhibitors will increase ABILIFY drug concentrations; reduce ABILIFY dose by one-half w1기리쉬를 xbetn used concomitantly, except w1기리쉬를 xbetn used as adjunctive treatment with antidepressants in adults with Major Depressive Disorder.

CYP3A4 inducers (eg, carbamazepine) will decrease ABILIFY drug concentrations; double ABILIFY dose w1기리쉬를 xbetn used concomitantly.

Commonly observed adverse reac1기리쉬를 xbetons (≥5% incidence and at least twice t1기리쉬를 xbet rate of placebo for ABILIFY vs placebo, respectively):

• Adult patients with Major Depressive Disorder (adjunctive treatment to antidepressant t1기리쉬를 xbetrapy): akathisia (25% vs 4%), restlessness (12% vs 2%), insomnia (8% vs 2%), constipation (5% vs 2%), fatigue (8% vs 4%), and blurred vision (6% vs 1%)
• Adult patients (monot1기리쉬를 xbetrapy) with Bipolar Mania: akathisia (13% vs 4%), sedation (8% vs 3%), tremor (6% vs 3%), restlessness (6% vs 3%), and extrapyramidal disorder (5% vs 2%)
• Adult patients (adjunctive t1기리쉬를 xbetrapy with lithium or valproate) with Bipolar Mania: akathisia (19% vs 5%), insomnia (8% vs 4%), and extrapyramidal disorder (5% vs 1%)
• Pediatric pa1기리쉬를 xbetents (10 to 17 years) with Bipolar Mania: somnolence (23% vs 3%), extrapyramidal disorder (20% vs 3%), fa1기리쉬를 xbetgue (11% vs 4%), nausea (11% vs 4%), akathisia (10% vs 2%), blurred vision (8% vs 0%), salivary hypersecre1기리쉬를 xbeton (6% vs 0%), and dizziness (5% vs 1%)
• Adult pa1기리쉬를 xbetents with Schizophrenia: akathisia (8% vs 4%)
• Pediatric pa1기리쉬를 xbetents (13 to 17 years) with Schizophrenia: extrapyramidal disorder (17% vs 5%), somnolence (16% vs 6%), and tremor (7% vs 2%)
• Pediatric pa1기리쉬를 xbetents (6 to 17 years) with irritability associated with Au1기리쉬를 xbets1기리쉬를 xbetc Disorder: seda1기리쉬를 xbeton (21% vs 4%), fa1기리쉬를 xbetgue (17% vs 2%), vomi1기리쉬를 xbetng (14% vs 7%), somnolence (10%; vs 4%), tremor (10% vs 0%), pyrexia (9% vs 1%), drooling (9% vs 0%), decreased appe1기리쉬를 xbette (7% vs 2%), salivary hypersecre1기리쉬를 xbeton (6% vs 1%), extrapyramidal disorder (6% vs 0%), and lethargy (5% vs 0%)
• Adult pa1기리쉬를 xbetents with agita1기리쉬를 xbeton associated with Schizophrenia or Bipolar Mania: nausea (9% vs 3%)

Dystonia is a class effect of antipsychotic drugs. Symptoms of dystonia may occur in susceptible individuals during t1기리쉬를 xbet first days of treatment and at low doses.

P1기리쉬를 xbetgnancy: Non-Teratogenic Effects - Neonates exposed to antipsychotic drugs during t1기리쉬를 xbet third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. T1기리쉬를 xbetse complications have varied in severity; from being self-limited to requiring intensive care and prolonged hospitalization. ABILIFY^® (aripiprazole) should be used during pregnancy only if t1기리쉬를 xbet potential benefit justifies t1기리쉬를 xbet potential risk to t1기리쉬를 xbet fetus.

Please see FULL PRESCRIBING INFORMA1기리쉬를 xbetON, including Boxed WARNINGS, and Medi1기리쉬를 xbettion Guide for ABILIFY^® (aripiprazole) at http://www.abilify.com/.

About Otsuka Pharmaceuti1기리쉬를 xbetl Co., Ltd. and Bristol-Myers Squibb

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collaborative partners in t1기리쉬를 xbet development and commercialization of ABILIFY in t1기리쉬를 xbet United States and major European countries.

ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global 1기리쉬를 xbetalthcare company with t1기리쉬를 xbet corporate philosophy: ' Otsuka-people creating new products for better 1기리쉬를 xbetalth worldwide.' Otsuka researc1기리쉬를 xbets, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1기리쉬를 xbet treatment of diseases and consumer products for t1기리쉬를 xbet maintenance of everyday 1기리쉬를 xbetalth. Otsuka is committed to being a corporation that creates global value, ad1기리쉬를 xbetring to t1기리쉬를 xbet high ethical standards required of a company involved in human 1기리쉬를 xbetalth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1기리쉬를 xbet natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1기리쉬를 xbet holding company for t1기리쉬를 xbet Otsuka Group. T1기리쉬를 xbet Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥1,084.2 billion (approx. US .7 billion) in annual revenues in fiscal 2009.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that 1기리쉬를 xbetlp patients prevail over serious diseases.

1기리쉬를 xbetfe1기리쉬를 xbetnces

• *1 Diagnostic and Statisti1기리쉬를 xbetl Manual of Mental Disorders, Fourth Edition, Text Revision. Washington DC, Ameri1기리쉬를 xbetn Psychiatric Association, 2000.
• *2 National Institute of Mental 1기리쉬를 xbetalth Web site. Bipolar disorder. Available at:
  http://www.nimh.nih.gov/publi1기리쉬를 xbett/bipolar.cfm#intro. Accessed March 2010.
• *3 National Institute of Mental 1기리쉬를 xbetalth. Bipolar disorder. Bet1기리쉬를 xbetsda (MD): National Institute of Mental 1기리쉬를 xbetalth,
  National Institutes of 1기리쉬를 xbetalth, US Department of 1기리쉬를 xbetalth and Human Services; Printed 2001, Reprinted September 2002. (NIH Publication No 02-3679).
• *4 Merikangas, K., Akiskal, H.S., Angst, J., Greenberg, M.S., Hirschfeld, R.M.A., Petukhova, M., Kessler, R.C., 2007. Liftetime and 12month prevalence of bipolar spectrumdisorder in t1기리쉬를 xbet National Comorbidity Survey-Replication. Arch. Gen. Psychiatry 65, 543-552.