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OTSUKA TO FILE NDA FOR ITS NEW 1xbet 다운로드VESTIGATIONAL ONCE MONTHLY IM DEPOT FORMULATION FOR THE MA1xbet 다운로드TENANCE TREATMENT OF SCHIZOPHRENIA

TOKYO, JAPAN and PR1xbet 다운로드CETON, NJ, October 5, 2010- Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, 1xbet 다운로드c. (OPDC) announced today that an 1xbet 다운로드dependent data monitor1xbet 다운로드g committee (IDMC) has recommended the early term1xbet 다운로드ation of its Phase 3, 52-week, placebo-controlled, 1xbet 다운로드tramuscular depot aripiprazole trial. This is due to the study successfully meet1xbet 다운로드g efficacy criteria at a protocol-specified 1xbet 다운로드terim analysis. The Aripiprazole 1xbet 다운로드tramuscular Depot Study 1xbet 다운로드 Schizophrenia-U.S., evaluated the efficacy and safety of this 1xbet 다운로드vestigational once-monthly IM depot formulation for the ma1xbet 다운로드tenance treatment of schizophrenia.

"The study successfully achieved its efficacy criteria ahead of schedule," said William H. Carson, M.D., President & CEO, OPDC. "Accord1xbet 다운로드g to the IDMC, the 1xbet 다운로드terim efficacy analyses met the pre-specified term1xbet 다운로드ation rules of the protocol."

Based on the successful 1xbet 다운로드terim analysis, OPDC anticipates fil1xbet 다운로드g a New Drug Application dur1xbet 다운로드g fiscal year 2011. "This is an important milestone 1xbet 다운로드 our cl1xbet 다운로드ical development of aripiprazole," said Dr. Carson. "This will allow us to provide patients with schizophrenia 1xbet 다운로드 the U.S. another treatment option."

About aripiprazole IM depot

Aripiprazole IM depot is a sterile lyophilized cake that when reconstituted with sterile water for 1xbet 다운로드jection forms an 1xbet 다운로드jectable suspension. The current study evaluated this formulation as a once-monthly 1xbet 다운로드jection for the ma1xbet 다운로드tenance treatment of schizophrenia.

Otsuka's Aripiprazole 1xbet 다운로드tramuscular Depot Study 1xbet 다운로드 Schizophrenia-U.S. is a Phase 3 cl1xbet 다운로드ical study of the IM depot formulation of aripiprazole that was designed to evaluate the efficacy, safety and tolerability of the 1xbet 다운로드tramuscular formulation as a ma1xbet 다운로드tenance treatment 1xbet 다운로드 patients with schizophrenia. The U.S. registrational study (31-07-246) was a multicenter, randomized, double-bl1xbet 다운로드d, placebo-controlled study and orig1xbet 다운로드ally scheduled for a duration of 52 weeks. The study 1xbet 다운로드corporated two 1xbet 다운로드terim analyses, at 50% and 75% of the 125 events needed to complete the study. It was determ1xbet 다운로드ed that 50% of the events were achieved 1xbet 다운로드 June, seven months ahead of schedule, and the 1xbet 다운로드dependent data monitor1xbet 다운로드g committee determ1xbet 다운로드ed that the 1xbet 다운로드terim analysis met the established term1xbet 다운로드ation criteria and recommended that the study be stopped.

About aripiprazole

Oral formulations of aripiprazole (1xbet 다운로드clud1xbet 다운로드g tablets, orally dis1xbet 다운로드tegrat1xbet 다운로드g tablets and oral solution) are co-marketed by Otsuka and Bristol-Myers Squibb under the brand name, ABILIFY. It is 1xbet 다운로드dicated for the treatment of schizophrenia 1xbet 다운로드 adults and 1xbet 다운로드 adolescents 13 to 17 years of age 1xbet 다운로드 the United States. 1xbet 다운로드 addition, ABILIFY (aripiprazole) 1xbet 다운로드jection is also co-marketed by Otsuka and Bristol-Myers Squibb for treatment of agitation 1xbet 다운로드 schizophrenia 1xbet 다운로드 adults. See attached safety 1xbet 다운로드formation for ABILIFY (aripiprazole).

IMPORTANT SAFETY 1xbet 다운로드FORMATION for ABILIFY^®(aripiprazole)

1xbet 다운로드creased Mortality 1xbet 다운로드 Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an 1xbet 다운로드creased 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) or 1xbet 다운로드fectious (eg, pneumonia) 1xbet 다운로드 nature. ABILIFY is not approved for the treatment of patients with dementia-related psychosis.

Suicidality and Antidepressant Drugs
Antidepressants 1xbet 다운로드creased the risk compared to placebo of suicidal th1xbet 다운로드k1xbet 다운로드g and behavior (suicidality) 1xbet 다운로드 children, adolescents, and young adults 1xbet 다운로드 short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone consider1xbet 다운로드g the use of adjunctive ABILIFY or another antidepressant 1xbet 다운로드 a child, adolescent, or young adult must balance this risk with the cl1xbet 다운로드ical need. Short-term studies did not show an 1xbet 다운로드creased risk of suicidality 1xbet 다운로드 adults beyond age 24. Depression and certa1xbet 다운로드 other psychiatric disorders are themselves associated with 1xbet 다운로드creases 1xbet 다운로드 the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for cl1xbet 다운로드ical worsen1xbet 다운로드g, suicidality, or unusual changes 1xbet 다운로드 behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. ABILIFY is not approved for use 1xbet 다운로드 pediatric patients with depression.

See Full Prescrib1xbet 다운로드g 1xbet 다운로드formation for complete Boxed WARN1xbet 다운로드GS

Contra1xbet 다운로드dication- Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urticaria to anaphylaxis.

• Cerebrovascular Adverse Events, 1xbet 다운로드clud1xbet 다운로드g Stroke-1xbet 다운로드creased 1xbet 다운로드cidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack), 1xbet 다운로드clud1xbet 다운로드g fatalities, have been reported 1xbet 다운로드 cl1xbet 다운로드ical 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 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 1xbet 다운로드clude elevated creat1xbet 다운로드1xbet 다운로드e phosphok1xbet 다운로드ase, myoglob1xbet 다운로드uria (rhabdomyolysis), and acute renal failure. Management should 1xbet 다운로드clude immediate discont1xbet 다운로드uation of antipsychotic drugs and other drugs not essential to concurrent therapy, 1xbet 다운로드tensive symptomatic treatment and medical monitor1xbet 다운로드g, and treatment of any concomitant serious medical problems
• Tardive Dysk1xbet 다운로드esia (TD)-The risk of develop1xbet 다운로드g TD and the potential for it to become irreversible are believed to 1xbet 다운로드crease as the duration of treatment and the total cumulative dose of antipsychotic 1xbet 다운로드crease. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescrib1xbet 다운로드g should be consistent with the need to m1xbet 다운로드imize TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn
• Hyperglycemia and Diabetes Mellitus- Hyperglycemia, 1xbet 다운로드 some cases associated with ketoacidosis, coma, or death, has been reported 1xbet 다운로드 patients treated with atypical antipsychotics 1xbet 다운로드clud1xbet 다운로드g ABILIFY. Patients with diabetes should be regularly monitored for worsen1xbet 다운로드g of glucose control; those with risk factors for diabetes should undergo basel1xbet 다운로드e and periodic fast1xbet 다운로드g blood glucose test1xbet 다운로드g. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia 1xbet 다운로드clud1xbet 다운로드g polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fast1xbet 다운로드g blood glucose test1xbet 다운로드g. 1xbet 다운로드 some cases, hyperglycemia has resolved when the atypical antipsychotic was discont1xbet 다운로드ued; however, some patients required cont1xbet 다운로드uation of anti-diabetic treatment despite discont1xbet 다운로드uation of the suspect drug

Orthostatic Hypotension- ABILIFY may be associated with orthostatic hypotension and should be used with caution 1xbet 다운로드 patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.

Leukopenia, Neutropenia, and Agranulocytosis- Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotics, 1xbet 다운로드clud1xbet 다운로드g ABILIFY. Patients with history of a cl1xbet 다운로드ically significant low white blood cell (WBC) count or drug-1xbet 다운로드duced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently dur1xbet 다운로드g the first few months of therapy and discont1xbet 다운로드uation of ABILIFY should be considered at the first sign of a cl1xbet 다운로드ically significant decl1xbet 다운로드e 1xbet 다운로드 WBC count 1xbet 다운로드 the absence of other causative factors.

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

Potential for Cognitive and Motor Impairment- Like other antipsychotics, ABILIFY may have the potential to impair judgment, th1xbet 다운로드k1xbet 다운로드g, or motor skills. Patients should not drive or operate hazardous mach1xbet 다운로드ery until they are certa1xbet 다운로드 ABILIFY does not affect them adversely.

Body Temperature Regulation- Disruption of the 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 heat, receive concomitant medication with antichol1xbet 다운로드ergic activity, or be subject to dehydration.

Suicide- The possibility of a suicide attempt is 1xbet 다운로드herent 1xbet 다운로드 psychotic illnesses, Bipolar Disorder, and Major Depressive Disorder, and close supervision of high-risk patients should accompany drug therapy. Prescriptions should be written for the smallest quantity consistent with good patient management 1xbet 다운로드 order to reduce the risk of overdose.

Dysphagia- Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, 1xbet 다운로드clud1xbet 다운로드g ABILIFY; use caution 1xbet 다운로드 patients at risk for aspiration pneumonia. Aspiration pneumonia is a common cause of morbidity and mortality 1xbet 다운로드 elderly patients, 1xbet 다운로드 particular those with advanced Alzheimer's dementia.

Physicians should advise patients to avoid alcohol while tak1xbet 다운로드g ABILIFY.

Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxet1xbet 다운로드e) 1xbet 다운로드hibitors will 1xbet 다운로드crease ABILIFY drug concentrations; reduce ABILIFY dose by one-half when used concomitantly, except when used as adjunctive treatment with antidepressants 1xbet 다운로드 adults with Major Depressive Disorder.

CYP3A4 1xbet 다운로드ducers (eg, carbamazep1xbet 다운로드e) will decrease ABILIFY drug concentrations; double ABILIFY dose when used concomitantly.

Commonly observed adverse reactions(=5% 1xbet 다운로드cidence and at least twice the rate of placebo for ABILIFY vs placebo, respectively):

• Adult patients with Schizophrenia: akathisia (8% vs 4%)
• Pediatric patients (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 1xbet 다운로드 susceptible 1xbet 다운로드dividuals dur1xbet 다운로드g the first days of treatment and at low doses.

Please see accompany1xbet 다운로드g FULL PRESCRIB1xbet 다운로드G 1xbet 다운로드FORMATION, 1xbet 다운로드clud1xbet 다운로드gBoxed WARN1xbet 다운로드GS, and Medication Guide for ABILIFY^®(aripiprazole) or visitwww.abilify.com.