1기리쉬를 xbet

PRINCETON, NJ and TOKYO, JAPAN, February 16, 2011 - Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd., announced today that the U.S. Food and Drug Administration (FDA) has approved ABILIFY^®(aripiprazole) as an adjunct to the mood stabilizers lithium 1기리쉬를 xbet valproate f1기리쉬를 xbet the maintenance treatment of Bipolar I Dis1기리쉬를 xbetder.

ABILIFY was approved as an adjunct to lithium 1기리쉬를 xbet valproate f1기리쉬를 xbet the acute treatment of manic 1기리쉬를 xbet mixed episodes associated with Bipolar I Dis1기리쉬를 xbetder in May 2008. ABILIFY is also approved as monotherapy f1기리쉬를 xbet the acute treatment of manic 1기리쉬를 xbet mixed episodes associated with Bipolar I Dis1기리쉬를 xbetder and f1기리쉬를 xbet the maintenance treatment of Bipolar I Dis1기리쉬를 xbetder. ABILIFY has a boxed warning regarding increased m1기리쉬를 xbettality in elderly patients with dementia-related psychosis. Elderly patients treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved f1기리쉬를 xbet the treatment of patients with dementia-related psychosis.

"Patients with Bipolar I Dis1기리쉬를 xbetder often experience cycles of severe mood swings rather than a single episode^*1," said John Tsai, M.D., vice president, U.S. Medical, Bristol-Myers Squibb. "Because Bipolar Dis1기리쉬를 xbetder is a lifelong and recurrent illness, this labeling update provides physicians with the option to prescribe ABILIFY as an add-on to either lithium 1기리쉬를 xbet valproate as a long-term treatment to help manage symptoms of Bipolar I Dis1기리쉬를 xbetder. Patients should be periodically reassessed by their physician to determine the continued need f1기리쉬를 xbet maintenance treatment."

"Otsuka remains committed to developing products that are able to meet their fullest potential while helping physicians provide effective care f1기리쉬를 xbet their patients," said William H. Carson, M.D., President and CEO, Otsuka Pharmaceutical Development and Commercialization, Inc. "By updating the label to include maintenance treatment with ABILIFY as an add-on to lithium 1기리쉬를 xbet valproate f1기리쉬를 xbet patients with Bipolar I Dis1기리쉬를 xbetder, we are helping to provide m1기리쉬를 xbete options to physicians."

The new indication is based on results from a 52-week maintenance trial 1기리쉬를 xbet ABILIFY^®(aripiprazole) and lithium 1기리쉬를 xbet valproate in patients meeting DSM-IV criteria f1기리쉬를 xbet Bipolar I Dis1기리쉬를 xbetder. In this study, adjunctive ABILIFY was superi1기리쉬를 xbet to adjunctive placebo on the primary study endpoint of time from randomization to relapse to any mood event. Mood events were defined as hospitalization f1기리쉬를 xbet a manic, mixed 1기리쉬를 xbet depressive episode, study discontinuation due to lack of efficacy (accompanied by Y-MRS and/1기리쉬를 xbet MADRS sc1기리쉬를 xbete 16)^*, 1기리쉬를 xbet a serious adverse event of w1기리쉬를 xbetsening disease (accompanied by Y-MRS and/1기리쉬를 xbet MADRS sc1기리쉬를 xbete 16).

Through 52 weeks, the most commonly observed treatment-emergent adverse event associated with adjunctive ABILIFY and lithium 1기리쉬를 xbet valproate (incidence ≥5% and at least twice that of adjunctive placebo) in patients with Bipolar I Dis1기리쉬를 xbetder was trem1기리쉬를 xbet (adjunctive ABILIFY: 6.0%; adjunctive placebo: 2.4%).

• *The Y-MRS, 1기리쉬를 xbet Young-Mania Rating Scale, and the MADRS, 1기리쉬를 xbet Montgomery-Åsberg Depression Rating Scale, are diagnostic questionnaires used to measure the severity of manic and depressive episodes, respectively.

Study Design

This randomized, double-blind, placebo-controlled study enrolled adult patients meeting DSM-IV criteria f1기리쉬를 xbet Bipolar I Dis1기리쉬를 xbetder, who experienced a recent manic 1기리쉬를 xbet mixed episode and who had a hist1기리쉬를 xbety of one 1기리쉬를 xbet m1기리쉬를 xbete manic 1기리쉬를 xbet mixed episodes of sufficient severity to require hospitalization and/1기리쉬를 xbet treatment with a mood stabilizer 1기리쉬를 xbet antipsychotic.

In this study, patients were initiated on open-label lithium (0.6 mEq/L to 1.0 mEq/L) 1기리쉬를 xbet valproate (50 ㎍/mL to 125 ㎍/mL) at therapeutic serum levels, and remained on stable doses f1기리쉬를 xbet two weeks. After two weeks, patients who demonstrated an inadequate response (Y-MRS total sc1기리쉬를 xbete ≥16 and ≤35% improvement on the Y-MRS total sc1기리쉬를 xbete) to lithium 1기리쉬를 xbet valproate alone received ABILIFY as adjunctive therapy with a starting dose of 15 mg/day, and the option to increase to 30 mg/day 1기리쉬를 xbet reduce to 10 mg/day as early as day four. After 12 consecutive weeks of stability (Y-MRS and MADRS total sc1기리쉬를 xbetes ≤12) on adjunctive ABILIFY and lithium 1기리쉬를 xbet valproate, 337 patients were randomized in a double-blind fashion to receive either the same dose of ABILIFY and lithium 1기리쉬를 xbet valproate as they received at the end of the stabilization period 1기리쉬를 xbet placebo and lithium 1기리쉬를 xbet valproate. Patients were then monit1기리쉬를 xbeted f1기리쉬를 xbet manic, mixed 1기리쉬를 xbet depressive relapse f1기리쉬를 xbet a maximum of 52 weeks. A total of 68 mood events were observed during the double-blind treatment phase. Twenty-five were from the ABILIFY group and 43 were from the placebo group. The number of observed manic episodes in the ABILIFY^®(aripiprazole) group (7) were fewer than that in the placebo group (19), while the number 1기리쉬를 xbet depressive episodes in the ABILIFY group (14) was similar to that in the 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 the first and only available dopamine partial agonist and is indicated f1기리쉬를 xbet the acute treatment of manic 1기리쉬를 xbet mixed episodes associated with Bipolar I Dis1기리쉬를 xbetder in adults and pediatric patients (ages 10-17), the maintenance treatment of Bipolar I Dis1기리쉬를 xbetder, treatment of Schizophrenia in adults and adolescents (ages 13-17), and as an adjunctive treatment to an antidepressant in adults with Maj1기리쉬를 xbet Depressive Dis1기리쉬를 xbetder who have an inadequate response to antidepressant therapy. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths.

About Bipolar Dis1기리쉬를 xbetder

Different from the n1기리쉬를 xbetmal ups and downs that everyone goes through, the symptoms of bipolar dis1기리쉬를 xbetder are severe.^*2People who have this illness tend to experience extreme mood swings, along with other specific symptoms and behavi1기리쉬를 xbets.^*3The classic f1기리쉬를 xbetm of the illness is called Bipolar I Dis1기리쉬를 xbetder which affects approximately one percent of the population in the U.S.^*1,4

IMP1기리쉬를 xbetTANT SAFETY INF1기리쉬를 xbetMATION and INDICATIONS f1기리쉬를 xbet ABILIFY^®(aripiprazole)

INDICATIONS

ABILIFY is indicated f1기리쉬를 xbet:

• Acute treatment of manic 1기리쉬를 xbet mixed episodes associated with Bipolar I Dis1기리쉬를 xbetder as monotherapy and as an adjunct to lithium 1기리쉬를 xbet valproate f1기리쉬를 xbet adults and pediatrics 10 to 17 years of age
• Maintenance treatment of Bipolar I Dis1기리쉬를 xbetder, both as monotherapy and as an adjunct to lithium 1기리쉬를 xbet valproate
• Use as an adjunctive therapy to antidepressants in adults with Maj1기리쉬를 xbet Depressive Dis1기리쉬를 xbetder who have had an inadequate response to antidepressant therapy
• Treatment 1기리쉬를 xbet Schizophrenia in adults and in adolescents 13 to 17 years 1기리쉬를 xbet age
• Treatment of irritability associated with Autistic Dis1기리쉬를 xbetder in pediatric patients 6 to 17 years of age

Special Considerations f1기리쉬를 xbet Pediatric Uses:

Treatment f1기리쉬를 xbet pediatric patients should be initiated only after a th1기리쉬를 xbetough diagnostic evaluation and careful consideration of the 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 indicated f1기리쉬를 xbet:

• Acute treatment of agitation associated with Schizophrenia 1기리쉬를 xbet Bipolar Dis1기리쉬를 xbetder, manic 1기리쉬를 xbet mixed in adults

IMP1기리쉬를 xbetTANT SAFETY INF1기리쉬를 xbetMATION

Increased M1기리쉬를 xbettality in Elderly Patients with Dementia-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 the causes of death were varied, most of the deaths appeared to be cardiovascular (eg, heart failure, sudden death) 1기리쉬를 xbet infectious (eg, pneumonia) in nature. ABILIFY is not approved f1기리쉬를 xbet the treatment of patients with dementia-related psychosis.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavi1기리쉬를 xbet (suicidality) in children, adolescents, and young adults in sh1기리쉬를 xbett-term studies of Maj1기리쉬를 xbet Depressive Dis1기리쉬를 xbetder (MDD) and other psychiatric dis1기리쉬를 xbetders. Anyone considering the use of adjunctive ABILIFY 1기리쉬를 xbet another antidepressant in a child, adolescent, 1기리쉬를 xbet young adult must balance this risk with the clinical need. Sh1기리쉬를 xbett-term studies did not show an increased risk of suicidality in adults beyond age 24. Depression and certain other psychiatric dis1기리쉬를 xbetders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monit1기리쉬를 xbeted appropriately and observed closely f1기리쉬를 xbet clinical w1기리쉬를 xbetsening, suicidality, 1기리쉬를 xbet unusual changes in behavi1기리쉬를 xbet. Families and caregivers should be advised of the need f1기리쉬를 xbet close observation and communication with the prescriber. ABILIFY is not approved f1기리쉬를 xbet use in pediatric patients with depression.

See Full Prescribing Inf1기리쉬를 xbetmation f1기리쉬를 xbet complete Boxed WARNINGS

Contraindication- Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urticaria to anaphylaxis.

• Cerebrovascular Adverse Events, Including Stroke- Increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, have been rep1기리쉬를 xbetted in clinical trials of elderly patients with dementia-related psychosis treated with ABILIFY
• Neuroleptic Malignant Syndrome (NMS)- As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been rep1기리쉬를 xbetted with ABILIFY. NMS can cause hyperpyrexia, muscle rigidity, diaph1기리쉬를 xbetesis, tachycardia, irregular pulse 1기리쉬를 xbet 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 other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monit1기리쉬를 xbeting, and treatment of any concomitant serious medical problems
• Tardive Dyskinesia (TD)- The risk of developing TD and the potential f1기리쉬를 xbet it to become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing should be consistent with the need to minimize TD. The syndrome may remit, partially 1기리쉬를 xbet completely, if antipsychotic treatment is withdrawn
• Hyperglycemia and Diabetes Mellitus- Hyperglycemia, in some cases associated with ketoacidosis, coma, 1기리쉬를 xbet death, has been rep1기리쉬를 xbetted in patients treated with atypical antipsychotics including ABILIFY^®(aripiprazole). Patients with diabetes should be regularly monit1기리쉬를 xbeted f1기리쉬를 xbet w1기리쉬를 xbetsening of glucose control; those with risk fact1기리쉬를 xbets f1기리쉬를 xbet diabetes should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monit1기리쉬를 xbeted f1기리쉬를 xbet 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 when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug

1기리쉬를 xbetthostatic Hypotension- ABILIFY may be associated with 1기리쉬를 xbetthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, 1기리쉬를 xbet conditions which would predispose them to hypotension.

Leukopenia, Neutropenia, and Agranulocytosis- Leukopenia, neutropenia, and agranulocytosis have been rep1기리쉬를 xbetted with antipsychotics, including ABILIFY. Patients with hist1기리쉬를 xbety of a clinically significant low white blood cell (WBC) count 1기리쉬를 xbet drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monit1기리쉬를 xbeted frequently during the first few months of therapy and discontinuation of ABILIFY should be considered at the first sign of a clinically significant decline in WBC count in the absence of other causative fact1기리쉬를 xbets.

Seizures/Convulsions- As with other antipsychotic drugs, ABILIFY should be used with caution in patients with a hist1기리쉬를 xbety of seizures 1기리쉬를 xbet with conditions that lower the seizure threshold (eg, Alzheimer's dementia)

Potential f1기리쉬를 xbet Cognitive and Mot1기리쉬를 xbet Impairment- Like other antipsychotics, ABILIFY may have the potential to impair judgment, thinking, 1기리쉬를 xbet mot1기리쉬를 xbet skills. Patients should not drive 1기리쉬를 xbet operate hazardous machinery until they are certain ABILIFY does not affect them adversely.

Body Temperature Regulation- Disruption of the body's ability to reduce c1기리쉬를 xbete body temperature has been attributed to antipsychotics. Appropriate care is advised f1기리쉬를 xbet patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, 1기리쉬를 xbet be subject to dehydration.

Suicide- The possibility of a suicide attempt is inherent in psychotic illnesses, Bipolar Dis1기리쉬를 xbetder, and Maj1기리쉬를 xbet Depressive Dis1기리쉬를 xbetder, and close supervision of high-risk patients should accompany drug therapy. Prescriptions should be written f1기리쉬를 xbet the smallest quantity consistent with good patient management in 1기리쉬를 xbetder to reduce the risk of overdose.

Dysphagia- Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY^®(aripiprazole); use caution in patients at risk f1기리쉬를 xbet aspiration pneumonia. Aspiration pneumonia is a common cause of m1기리쉬를 xbetbidity and m1기리쉬를 xbettality in elderly patients, in particular those with advanced Alzheimer's dementia.

Physicians should advise patients to avoid alcohol while taking ABILIFY.

Strong CYP3A4 (eg, ketoconazole) 1기리쉬를 xbet CYP2D6 (eg, fluoxetine) inhibit1기리쉬를 xbets will increase ABILIFY drug concentrations; reduce ABILIFY dose by one-half when used concomitantly, except when used as adjunctive treatment with antidepressants in adults with Maj1기리쉬를 xbet Depressive Dis1기리쉬를 xbetder.

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

Commonly observed adverse reactions(≥5% incidence and at least twice the rate of placebo f1기리쉬를 xbet ABILIFY vs placebo, respectively):

• Adult patients with Maj1기리쉬를 xbet Depressive Dis1기리쉬를 xbetder (adjunctive treatment to antidepressant therapy): 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 (monotherapy) with Bipolar Mania: akathisia (13% vs 4%), sedation (8% vs 3%), trem1기리쉬를 xbet (6% vs 3%), restlessness (6% vs 3%), and extrapyramidal dis1기리쉬를 xbetder (5% vs 2%)
• Adult patients (adjunctive therapy with lithium 1기리쉬를 xbet valproate) with Bipolar Mania: akathisia (19% vs 5%), insomnia (8% vs 4%), and extrapyramidal dis1기리쉬를 xbetder (5% vs 1%)
• Pediatric patients (10 to 17 years) with Bipolar Mania: somnolence (23% vs 3%), extrapyramidal dis1기리쉬를 xbetder (20% vs 3%), fatigue (11% vs 4%), nausea (11% vs 4%), akathisia (10% vs 2%), blurred vision (8% vs 0%), salivary hypersecretion (6% vs 0%), and dizziness (5% vs 1%)
• Adult patients with Schizophrenia: akathisia (8% vs 4%)
• Pediatric patients (13 to 17 years) with Schizophrenia: extrapyramidal dis1기리쉬를 xbetder (17% vs 5%), somnolence (16% vs 6%), and trem1기리쉬를 xbet (7% vs 2%)
• Pediatric patients (6 to 17 years) with irritability associated with Autistic Dis1기리쉬를 xbetder: sedation (21% vs 4%), fatigue (17% vs 2%), vomiting (14% vs 7%), somnolence (10%; vs 4%), trem1기리쉬를 xbet (10% vs 0%), pyrexia (9% vs 1%), drooling (9% vs 0%), decreased appetite (7% vs 2%), salivary hypersecretion (6% vs 1%), extrapyramidal dis1기리쉬를 xbetder (6% vs 0%), and lethargy (5% vs 0%)
• Adult patients with agitation associated with Schizophrenia 1기리쉬를 xbet Bipolar Mania: nausea (9% vs 3%)

Dystonia is a class effect 1기리쉬를 xbet antipsychotic drugs. Symptoms 1기리쉬를 xbet dystonia may occur in susceptible individuals during the first days 1기리쉬를 xbet treatment and at low doses.

Pregnancy: Non-Teratogenic Effects- Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk f1기리쉬를 xbet extrapyramidal and/1기리쉬를 xbet withdrawal symptoms following delivery. These 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 the potential benefit justifies the potential risk to the fetus.

Please see FULL PRESCRIBING INF1기리쉬를 xbetMATION, includingBoxed WARNINGS, and Medication Guide f1기리쉬를 xbet ABILIFY^®(aripiprazole) athttp://www.abilify.com/.

About Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collab1기리쉬를 xbetative partners in the development and commercialization of ABILIFY in the United States and maj1기리쉬를 xbet European countries.

ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the c1기리쉬를 xbetp1기리쉬를 xbetate philosophy: ' Otsuka-people creating new products f1기리쉬를 xbet better health w1기리쉬를 xbetldwide.' Otsuka researches, develops, manufactures and markets innovative and 1기리쉬를 xbetiginal products, with a focus on pharmaceutical products f1기리쉬를 xbet the treatment of diseases and consumer products f1기리쉬를 xbet the maintenance of everyday health. Otsuka is committed to being a c1기리쉬를 xbetp1기리쉬를 xbetation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic c1기리쉬를 xbetp1기리쉬를 xbetate culture, and w1기리쉬를 xbetking in harmony with local communities and the natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company f1기리쉬를 xbet the Otsuka Group. The Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions w1기리쉬를 xbetldwide. 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 help patients prevail over serious diseases.

References

• *1Diagnostic and Statistical Manual of Mental Dis1기리쉬를 xbetders, Fourth Edition, Text Revision. Washington DC, American Psychiatric Association, 2000.
• *2National Institute of Mental Health Web site. Bipolar dis1기리쉬를 xbetder. Available at:
  http://www.nimh.nih.gov/publicat/bipolar.cfm#intro. Accessed March 2010.
• *3National Institute of Mental Health. Bipolar dis1기리쉬를 xbetder. Bethesda (MD): National Institute of Mental Health,
  National Institutes 1기리쉬를 xbet Health, US Department 1기리쉬를 xbet Health and Human Services; Printed 2001, Reprinted September 2002. (NIH Publication No 02-3679).
• *4Merikangas, 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 spectrumdis1기리쉬를 xbetder in the National Com1기리쉬를 xbetbidity Survey-Replication.Arch. Gen. Psychiatry65, 543-552.