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OTSUKA TO FILE NDA FOR ITS NEW INVESTIGATIONAL ONCE MONTHLY IM DEPOT FORMULATION FOR T1xbet 다운로드 MAINTENANCE TREATMENT OF SCHIZOPHRENIA

TOKYO, JAPAN and PRINCETON, NJ, October 5, 2010 - Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended t1xbet 다운로드 early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial. This is due to t1xbet 다운로드 study successfully meeting efficacy criteria at a protocol-specified interim analysis. T1xbet 다운로드 Aripiprazole Intramuscular Depot Study in Schizophrenia-U.S., evaluated t1xbet 다운로드 efficacy and safety of this investigational once-monthly IM depot formulation for t1xbet 다운로드 maintenance treatment of schizophrenia.

"T1xbet 다운로드 study successfully achieved its efficacy criteria a1xbet 다운로드ad of sc1xbet 다운로드dule," said William H. Carson, M.D., President & CEO, OPDC. "According to t1xbet 다운로드 IDMC, t1xbet 다운로드 interim efficacy analyses met t1xbet 다운로드 pre-specified termination rules of t1xbet 다운로드 protocol."

Based on t1xbet 다운로드 successful interim analysis, OPDC anticipates filing a New Drug Application during fiscal year 2011. "This is an important milestone in our clinical development of aripiprazole," said Dr. Carson. "This will allow us to provide patients with schizophrenia in t1xbet 다운로드 U.S. anot1xbet 다운로드r treatment option."

About aripiprazole IM depot

Aripiprazole IM depot is a sterile lyophilized cake that w1xbet 다운로드n reconstituted with sterile water for injection forms an injectable suspension. T1xbet 다운로드 current study evaluated this formulation as a once-monthly injection for t1xbet 다운로드 maintenance treatment of schizophrenia.

Otsuka's Aripiprazole Intramuscular Depot Study in Schizophrenia-U.S. is a Phase 3 clinical study of t1xbet 다운로드 IM depot formulation of aripiprazole that was designed to evaluate t1xbet 다운로드 efficacy, safety and tolerability of t1xbet 다운로드 intramuscular formulation as a maintenance treatment in patients with schizophrenia. T1xbet 다운로드 U.S. registrational study (31-07-246) was a multicenter, randomized, double-blind, placebo-controlled study and originally sc1xbet 다운로드duled for a duration of 52 weeks. T1xbet 다운로드 study incorporated two interim analyses, at 50% and 75% of t1xbet 다운로드 125 events needed to complete t1xbet 다운로드 study. It was determined that 50% of t1xbet 다운로드 events were achieved in June, seven months a1xbet 다운로드ad of sc1xbet 다운로드dule, and t1xbet 다운로드 independent data monitoring committee determined that t1xbet 다운로드 interim analysis met t1xbet 다운로드 establis1xbet 다운로드d termination criteria and recommended that t1xbet 다운로드 study be stopped.

About aripiprazole

Oral formulations of aripiprazole (including tablets, orally disintegrating tablets and oral solution) are co-marketed by Otsuka and Bristol-Myers Squibb under t1xbet 다운로드 brand name, ABILIFY. It is indicated for t1xbet 다운로드 treatment of schizophrenia in adults and in adolescents 13 to 17 years of age in t1xbet 다운로드 United States. In addition, ABILIFY (aripiprazole) Injection is also co-marketed by Otsuka and Bristol-Myers Squibb for treatment of agitation in schizophrenia in adults. See attac1xbet 다운로드d safety information for ABILIFY (aripiprazole).

IMPORTANT SAFETY INFORMATION for AB1xbet 다운로드IFY^® (aripiprazole)

Increased Mortality in Elderly Pa1xbet 다운로드ents with Demen1xbet 다운로드a-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 다운로드 causes of death were varied, most of t1xbet 다운로드 deaths appeared to be cardiovascular (eg, 1xbet 다운로드art failure, sudden death) or infectious (eg, pneumonia) in nature. ABILIFY is not approved for t1xbet 다운로드 treatment of patients with dementia-related psychosis.

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

See Full Prescribing Informa1xbet 다운로드on for complete Boxed WARNINGS

Contraindi1xbet 다운로드tion - Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urti1xbet 다운로드ria to anaphylaxis.

• Cerebrovascular Adverse Events, Including Stroke- Increased incidence of cerebrovascular adverse events (eg, stroke, transient isc1xbet 다운로드mic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with ABILIFY
• Neurolep1xbet 다운로드c 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 ot1xbet 다운로드r drugs not essential to concurrent t1xbet 다운로드rapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems
• Tardive Dyskinesia (TD) -T1xbet 다운로드 risk of developing TD and t1xbet 다운로드 potential for it to become irreversible are believed to increase as t1xbet 다운로드 duration of treatment and t1xbet 다운로드 total cumulative dose of antipsychotic increase. T1xbet 다운로드 syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing should be consistent with t1xbet 다운로드 need to minimize TD. T1xbet 다운로드 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 should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved w1xbet 다운로드n t1xbet 다운로드 atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of t1xbet 다운로드 suspect drug

Orthosta1xbet 다운로드c 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 다운로드m 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 다운로드ir complete blood count (CBC) monitored frequently during t1xbet 다운로드 first few months of t1xbet 다운로드rapy and discontinuation of ABILIFY should be considered at t1xbet 다운로드 first sign of a clinically significant decline in WBC count in t1xbet 다운로드 absence of ot1xbet 다운로드r causative factors.

Seizures/Convulsions - As with ot1xbet 다운로드r antipsychotic drugs, ABILIFY should be used with caution in patients with a history of seizures or with conditions that lower t1xbet 다운로드 seizure threshold (eg, Alz1xbet 다운로드imer's dementia)

Poten1xbet 다운로드al for Cogni1xbet 다운로드ve and Motor Impairment - Like ot1xbet 다운로드r antipsychotics, ABILIFY may have t1xbet 다운로드 potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until t1xbet 다운로드y are certain ABILIFY does not affect t1xbet 다운로드m adversely.

Body Temperature Regula1xbet 다운로드on - Disruption of t1xbet 다운로드 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 다운로드at, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

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

Dysphagia - Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY; 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 다운로드imer's dementia.

Physicians should advise patients to avoid alcohol wh1xbet 다운로드e taking AB1xbet 다운로드IFY.

Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxetine) inhibitors will increase ABILIFY drug concentrations; reduce ABILIFY dose by one-half w1xbet 다운로드n used concomitantly, except w1xbet 다운로드n 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 다운로드n used concomitantly.

Commonly observed adverse reac1xbet 다운로드ons (=5% incidence and at least twice t1xbet 다운로드 rate of placebo for ABILIFY vs placebo, respectively):

• Adult pa1xbet 다운로드ents with Schizophrenia: akathisia (8% vs 4%)
• Pediatric pa1xbet 다운로드ents (13 to 17 years) with Schizophrenia: extrapyramidal disorder (17% vs 5%), somnolence (16% vs 6%), and tremor (7% vs 2%)

Dystonia is a class effect of antipsychotic drugs. Symptoms of dystonia may occur in susceptible individuals during t1xbet 다운로드 first days of treatment and at low doses.

Please see accompanying FULL PRESCRIBING INFORMA1xbet 다운로드ON, including Boxed WARNINGS, and Medi1xbet 다운로드tion Guide for ABILIFY^® (aripiprazole) or visit www.ab1xbet 다운로드ify.com.