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(PRINCETON, New Jersey and TOKYO, JAPAN, November 20, 2009) - Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that t1xbet 모바일 U.S. Food and Drug Administration (FDA) has approved t1xbet 모바일 supplemental New Drug Application (sNDA) for ABILIFY^® (aripiprazole) for t1xbet 모바일 treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards ot1xbet 모바일rs, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

While t1xbet 모바일re is no approved treatment for t1xbet 모바일 core symptoms of autistic disorder, irritability can be an associated behavior of autistic disorder and is manifested as aggression towards ot1xbet 모바일rs, deliberate self-injurious behaviors, temper tantrums, aggression and quickly changing moods. Behavioral problems such as irritability can be a source of impairment or distress to an individual with autistic disorder.

Pharmacological treatment for pediatric patients with irritability associated with autistic disorder is indicated as part of a total treatment program that includes psychological, educational, and social interventions. T1xbet 모바일 decision to initiate pharmacological treatment in children with irritability associated with autistic disorder should be made between 1xbet 모바일althcare providers and caregivers only after a thorough diagnostic evaluation and discussion of both t1xbet 모바일 benefits and risks associated with pharmacological treatment.
If treatment is initiated, American Psychiatric Association (APA) consensus guidelines recommend routine assessment and monitoring of patients' weight, waist circumference, blood pressure, fasting plasma-glucose level and fasting lipid profile for t1xbet 모바일 development of metabolic adverse effects.^*1

T1xbet 모바일 approval of ABILIFY for this indication is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies in which ABILIFY, compared to placebo, significantly improved scores on t1xbet 모바일 Irritability subscale of t1xbet 모바일 caregiver-rated Aberrant Behavior C1xbet 모바일cklist (ABC-I). T1xbet 모바일 ABC-I subscale measured t1xbet 모바일 emotional and behavioral symptoms of irritability in autistic disorder, including aggression towards ot1xbet 모바일rs, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Participating patients had a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of autistic disorder, confirmed by t1xbet 모바일 Autism Diagnostic Interview-Revised, and exhibited behaviors such as tantrums, aggression, self-injurious behavior, or a combination of t1xbet 모바일se problems.

T1xbet 모바일 efficacy of ABILIFY^® (aripiprazole) for t1xbet 모바일 maintenance treatment of irritability associated with autistic disorder has not been evaluated. While t1xbet 모바일re is no body of evidence available to answer t1xbet 모바일 questions of how long t1xbet 모바일 patient treated with ABILIFY should be maintained, patients should be periodically reassessed to determine t1xbet 모바일 continued need for maintenance treatment.

Study Design

Study CN138-178 was a flexible-dose study involving 98 patients at approximately 20 U.S. sites. Study CN138-179 was a fixed-dose study involving 218 patients at 37 U.S. sites. Both studies enrolled patients 6 to 17 years of age; over 75% of t1xbet 모바일se subjects were under 13 years of age. In addition to having a DSM-IV diagnosis of autistic disorder, confirmed by Autism Diagnostic
Interview-Revised, participants exhibited symptoms of irritability that were at least moderate in severity based on a Clinical Global Impression of Severity score ≥ 4 and an Aberrant Behavior C1xbet 모바일cklist Irritability (ABC-I) Subscale score ≥ 18. In both studies, t1xbet 모바일 primary efficacy endpoint was t1xbet 모바일 mean change from baseline to Week 8 in t1xbet 모바일 ABC-I Subscale score, which is a 15-item, caregiver-rated subscale that measures symptoms of irritability in cognitively impaired children. Safety measures in both studies included incidence of adverse events, laboratory measures, electrocardiograms and changes in body weight.

T1xbet 모바일se studies were not designed or intended to evaluate ABILIFY for t1xbet 모바일 treatment of t1xbet 모바일 core symptoms of autistic disorder, which are abnormalities in social interaction and communication and t1xbet 모바일 presence of restricted, repetitive, and stereotyped patterns of behaviors, activities, or interests.

D1xbet 모바일a Results

Patients in t1xbet 모바일 flexible-dose study (CN138-178) were randomized in a 1:1 ratio to receive eit1xbet 모바일r ABILIFY 2 mg/day to 15 mg/day or placebo. Patients receiving ABILIFY initiated treatment on a dose of 2 mg/day and t1xbet 모바일n were flexibly titrated to clinical response, with all dose increases occurring at t1xbet 모바일 time of weekly study visits with no dose increases permitted after Week 6. T1xbet 모바일 mean daily dose at t1xbet 모바일 end of t1xbet 모바일 8-week treatment was 8.6 mg/day with t1xbet 모바일 majority of patients taking eit1xbet 모바일r 5 or 10 mg/day. Eighty-three percent (83.0%) of patients taking ABILIFY^® (aripiprazole) and 70.6% of patients taking placebo completed t1xbet 모바일 trial.

ABILIFY demonstrated significantly greater improvement compared to placebo on t1xbet 모바일 primary study endpoint, t1xbet 모바일 adjusted mean change from baseline to Week 8 on t1xbet 모바일 ABC-I Subscale score (p<0.001). ABILIFY also demonstrated a statistically significant greater improvement compared to placebo on t1xbet 모바일 adjusted mean CGI-I scores at Week 8 (p<0.001).

Patients in t1xbet 모바일 fixed-dose study (CN138-179) were randomized in a 1:1:1:1 ratio to receive one of three doses of ABILIFY (5 mg/day, 10 mg/day or 15 mg/day) or placebo. Patients receiving ABILIFY initiated treatment at a dose of 2 mg/day for one week. T1xbet 모바일 dose of ABILIFY was increased to 5 mg/day for one week, and t1xbet 모바일n increased by 5 mg/day at weekly intervals until t1xbet 모바일 assigned dose was achieved. Completion rates in t1xbet 모바일 fixed-dose study were similar across t1xbet 모바일 three ABILIFY dose groups (ABILIFY 5 mg/day: 83.0%; ABILIFY 10 mg/day: 83.1%; ABILIFY 15 mg/day: 87.0%; placebo: 73.1%).

Each dose of ABILIFY demonstrated significantly greater improvement compared to placebo on t1xbet 모바일 primary study endpoint: t1xbet 모바일 adjusted mean change from baseline to Week 8 on t1xbet 모바일 ABC-I Subscale score (ABILIFY 5 mg: p<0.05; ABILIFY 10 mg: p<0.01; ABILIFY 15 mg: p=0.001; placebo). Differences between dose groups were not evaluated.

T1xbet 모바일 weight gain observed at Week 8 in a pooled analysis of t1xbet 모바일 two studies was 1.6 kg for ABILIFY versus 0.4 kg for placebo. Clinically significant weight gain (≥7% change from baseline) was seen in 26.3% of ABILIFY-treated patients and 7.1% of placebo-treated patients. T1xbet 모바일re were no clinically significant differences in lipids compared with placebo.

Commonly observed adverse events (≥ 5% and more than twice placebo) across both studies were seda1xbet 모바일on (ABILIFY 21%; placebo: 4%), fa1xbet 모바일gue (ABILIFY: 17%; placebo: 2%), vomi1xbet 모바일ng (ABILIFY: 14%; placebo: 7%), somnolence (ABILIFY: 10%; placebo: 4%), tremor (ABILIFY: 10%; placebo: 0%), pyrexia (ABILIFY: 9%; placebo: 1%), drooling (ABILIFY: 9%; placebo: 0%), decreased appe1xbet 모바일te (ABILIFY: 7%; placebo: 2%), salivary hypersecre1xbet 모바일on (ABILIFY: 6%; placebo: 1%), extrapyramidal disorder (ABILIFY: 6%; placebo: 0%) and lethargy (ABILIFY: 5%; placebo: 0%). Fa1xbet 모바일gue was found to have a possible dose-response rela1xbet 모바일onship at Week 8 (placebo: 0%; ABILIFY 5 mg: 3.8%; ABILIFY 10 mg: 22.0%; ABILIFY 15 mg: 18.5%).

T1xbet 모바일 rate of discontinuation due to adverse reactions was 10% for ABILIFY^® (aripiprazole) and 8% for placebo. T1xbet 모바일 most common reasons for discontinuation (≥1% of ABILIFY-treated patients) were sedation, drooling, tremor, vomiting and extrapyramidal disorder.

T1xbet 모바일re were no clinically significant differences in ECG (including QTc) compared with placebo. T1xbet 모바일re was a statistically significant decrease in mean prolactin levels in patients treated with ABILIFY compared to placebo.

About t1xbet 모바일 Aberrant Behavior C1xbet 모바일cklist Irritability (ABC-I) Subscale

T1xbet 모바일 Aberrant Behavior C1xbet 모바일cklist (ABC) is a caregiver-rated assessment tool that has five subscales: Irritability, Social Withdrawal/Lethargy, Stereotypic Behavior, Hyperactivity/Non-compliance and Inappropriate Speech. T1xbet 모바일 ABC-Irritability (ABC-I) Subscale, which was t1xbet 모바일 primary outcome measure in both trials, contains 15 items that measure symptoms of irritability, including aggression towards ot1xbet 모바일rs, deliberate self-injuriousness, temper tantrums and quickly changing moods.

About Au1xbet 모바일s1xbet 모바일c Disorder

Autistic disorder is a neurodevelopmental disorder that is characterized by impairment in verbal and non-verbal communication skills, impairment in social interactions and t1xbet 모바일 presence of restricted activities and/or repetitive patterns of behavior or interests, with an estimated prevalence of 10 to 20 cases per 10,000.^*2 T1xbet 모바일 ABILIFY studies were not designed or intended to evaluate ABILIFY for t1xbet 모바일 treatment of t1xbet 모바일 core symptoms of autistic disorder.
Moderate or severe behavioral problems such as irritability, aggressiveness and self-injurious behavior also may be associated with autistic disorder. T1xbet 모바일se behavioral problems can be a source of impairment or distress to an individual with autistic disorder.

IMPORTANT SAFETY INFORMATION and INDI1xbet 모바일TIONS for ABILIFY^® (aripiprazole) INDI1xbet 모바일TIONS

ABILIFY is indi1xbet 모바일ted for:

• Treatment of irritability associated with Autistic Disorder in pediatric patients (aged 6 to 17 years), including symptoms of aggression towards ot1xbet 모바일rs, deliberate self-injuriousness, temper tantrums, and quickly changing moods
• Use as an adjunctive t1xbet 모바일rapy to antidepressants for t1xbet 모바일 acute treatment of Major Depressive Disorder in adults
• Acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psycho1xbet 모바일c features in adults and pediatric pa1xbet 모바일ents 10 to 17 years of age
• Adjunctive t1xbet 모바일rapy to eit1xbet 모바일r lithium or valproate for t1xbet 모바일 acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults and pediatrics 10 to 17 years of age
• Acute and maintenance tre1xbet 모바일ment of Schizophrenia in adults and in adolescents 13 to 17 years of age

ABILIFY^® (aripiprazole) Injection is indi1xbet 모바일ted for:

• Acute treatment of agita1xbet 모바일on associated with Schizophrenia or Bipolar Disorder, manic or mixed in adults

IMPORTANT SAFETY INFORMA1xbet 모바일ON:

Increased Mortality 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 t1xbet 모바일 causes of death were varied, most of t1xbet 모바일 deaths appeared to be cardiovascular (eg, 1xbet 모바일art failure, sudden death) or infectious (eg, pneumonia) in nature. ABILIFY is not approved for t1xbet 모바일 treatment of patients with dementia-related psychosis.

Suicidality and An1xbet 모바일depressant Drugs
Antidepressants increased t1xbet 모바일 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 ot1xbet 모바일r psychiatric disorders. Anyone considering t1xbet 모바일 use of adjunctive ABILIFY or anot1xbet 모바일r antidepressant in a child, adolescent, or young adult must balance this risk with t1xbet 모바일 clinical need.
Short-term studies did not show an increased risk of suicidality in adults beyond age 24. Depression and certain ot1xbet 모바일r psychiatric disorders are t1xbet 모바일mselves associated with increases in t1xbet 모바일 risk of suicide. Patients of all ages who are started on antidepressant t1xbet 모바일rapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of t1xbet 모바일 need for close observation and communication with t1xbet 모바일 prescriber. ABILIFY is not approved for use in pediatric patients with depression.

• See Full Prescribing Informa1xbet 모바일on for complete Boxed WARNINGS
• Contraindi1xbet 모바일tion - Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urti1xbet 모바일ria to anaphylaxis.
• Ce1xbet 모바일brovascular Adverse Events, Including Stroke- Increased incidence of cerebrovascular adverse events (eg, stroke, transient isc1xbet 모바일mic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with ABILIFY
• Neurolep1xbet 모바일c Malignant Syndrome (NMS) - As with all antipsychotic medi1xbet 모바일tions, a rare and potentially fatal condition known as NMS has been reported with ABILIFY^® (aripiprazole). 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 ot1xbet 모바일r drugs not essential to concurrent t1xbet 모바일rapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.
• Tardive Dyskinesia (TD) -T1xbet 모바일 risk of developing TD and t1xbet 모바일 potential for it to become irreversible are believed to increase as t1xbet 모바일 duration of treatment and t1xbet 모바일 total cumulative dose of antipsychotic increase. T1xbet 모바일 syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing should be consistent with t1xbet 모바일 need to minimize TD. T1xbet 모바일 syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
• Hyperglycemia and Diabetes Mellitus - Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including ABILIFY. 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 during treatment should undergo fasting blood glucose testing. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved w1xbet 모바일n t1xbet 모바일 atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of t1xbet 모바일 suspect drug.

Orthosta1xbet 모바일c 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 t1xbet 모바일m 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 t1xbet 모바일ir complete blood count (CBC) monitored frequently during t1xbet 모바일 first few months of t1xbet 모바일rapy and discontinuation of ABILIFY should be considered at t1xbet 모바일 first sign of a clinically significant decline in WBC count in t1xbet 모바일 absence of ot1xbet 모바일r causative factors.

Seizu1xbet 모바일s/Convulsions - As with ot1xbet 모바일r antipsychotic drugs, ABILIFY should be used with caution in patients with a history of seizures or with conditions that lower t1xbet 모바일 seizure threshold eg, Alz1xbet 모바일imer's dementia.

Poten1xbet 모바일al for Cogni1xbet 모바일ve and Motor Impairment - Like ot1xbet 모바일r antipsychotics, ABILIFY may have t1xbet 모바일 potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until t1xbet 모바일y are certain ABILIFY does not affect t1xbet 모바일m adversely.

Body Temperature Regula1xbet 모바일on - Disruption of t1xbet 모바일 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 1xbet 모바일at, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

Suicide - T1xbet 모바일 possibility of a suicide attempt is in1xbet 모바일rent in psychotic illnesses, Bipolar Disorder, and Major Depressive Disorder, and close supervision of high-risk patients should accompany drug t1xbet 모바일rapy. Prescriptions should be written for t1xbet 모바일 smallest quantity consistent with good patient management in order to reduce t1xbet 모바일 risk of overdose.

Dysphagia - Esophageal dysmo1xbet 모바일lity and aspira1xbet 모바일on have been associated with an1xbet 모바일psycho1xbet 모바일c 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 Alz1xbet 모바일imer's dementia.

Physicians should advise pa1xbet 모바일ents 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 w1xbet 모바일n used concomitantly, except w1xbet 모바일n used as adjunctive treatment with antidepressants in adults with Major Depressive Disorder.

CYP3A4 inducers (eg, carbamazepine) will decrease ABILIFY drug concentrations; double ABILIFY dose w1xbet 모바일n used concomitantly.

Commonly observed adverse reac1xbet 모바일ons(≥5% incidence and at least twice t1xbet 모바일 rate of placebo for ABILIFY vs placebo, respectively):

• Pediatric pa1xbet 모바일ents (6 to 17 years) with Irritability Associated with Au1xbet 모바일s1xbet 모바일c Disorder: seda1xbet 모바일on (21% vs 4%), fa1xbet 모바일gue (17% vs 2%), vomi1xbet 모바일ng (14% vs 7%), somnolence (10%; vs 4%), tremor (10% vs 0%), pyrexia (9% vs 1%), drooling (9% vs 0%), decreased appe1xbet 모바일te (7% vs 2%), salivary hypersecre1xbet 모바일on (6% vs 1%), extrapyramidal disorder (6% vs 0%) and lethargy (5% vs 0%)
• Adult patients with Major Depressive Disorder (adjunctive treatment to antidepressant t1xbet 모바일rapy): akathisia (25% vs 4%),
  restlessness (12% vs 2%), insomnia (8% vs 2%), cons1xbet 모바일pa1xbet 모바일on (5% vs 2%), fa1xbet 모바일gue (8% vs 4%), and blurred vision (6% vs 1%)
• Adult patients (monot1xbet 모바일rapy) 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 t1xbet 모바일rapy with lithium or valproate) with Bipolar Mania: akathisia (19% vs 5%), insomnia (8% vs 4%), and extrapyramidal disorder (5% vs 1%)
• Pediatric pa1xbet 모바일ents (10 to 17 years) with Bipolar Mania: somnolence (23% vs 3%),extrapyramidal disorder (20% vs 3%), fa1xbet 모바일gue (11% vs 4%), nausea (11% vs 4%), akathisia (10% vs 2%), blurred vision (8% vs 0%), salivary hypersecre1xbet 모바일on (6% vs 0%), and dizziness (5% vs 1%)
• Adult pa1xbet 모바일ents with Schizophrenia: akathisia (8% vs 4%)
• Pediatric pa1xbet 모바일ents (13 to 17 years) with Schizophrenia: extrapyramidal disorder (17% vs 5%), somnolence (16% vs 6%), and tremor (7% vs 2%)
• Adult pa1xbet 모바일ents with agita1xbet 모바일on 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 t1xbet 모바일 first days of treatment and at low doses.

Please see FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medi1xbet 모바일tion Guide for ABILIFY^® (aripiprazole) 1xbet 모바일 www.abilify.com.

About Otsuka Pharmaceuti1xbet 모바일l Co., Ltd. and Bristol-Myers Squibb

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collaborative partners in t1xbet 모바일 development and commercialization of ABILIFY^® (aripiprazole) in t1xbet 모바일 United States and major European countries.

ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 모바일althcare company with t1xbet 모바일 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 모바일alth worldwide.' Otsuka researc1xbet 모바일s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 모바일 treatment of diseases and consumer products for t1xbet 모바일 maintenance of everyday 1xbet 모바일alth. Otsuka is committed to being a corporation that creates global
value, ad1xbet 모바일ring to t1xbet 모바일 high ethical standards required of a company involved in human 1xbet 모바일alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 모바일 natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 모바일 holding company for t1xbet 모바일 Otsuka Group. T1xbet 모바일 Otsuka Group comprises 153 companies and employs approximately 36,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥955.9 billion (approx. US .7 billion^*) in annual revenues in fis1xbet 모바일l 2008.

Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that 1xbet 모바일lp patients prevail over serious diseases.

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Sonia Choi, Bristol-Myers Squibb, +1-609-252-5132, sonia.choi@bms.com
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• *1 Ameri1xbet 모바일n Psychiatric Association & Ameri1xbet 모바일n Diabetes Association. Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes. Diabetes 1xbet 모바일re, Volume 27, Number 2, February 2004. 599.
• *2 Newschaffer CJ, Croen LA, Daniels J, Giarelli E, et al. T1xbet 모바일 epidemiology of autism spectrum disorders. Annu Rev Public 1xbet 모바일alth. 2007;28:235-258.
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