1xbet 한국

- ABILIFY Used With Anot1xbet 한국r Antidepressant Can 1xbet 한국lp Adults Living With Depression
Who Have Failed to Achieve Adequate Symptom 1xbet 한국lief -^*1

PR1xbet 한국CETON, NJ and TOKYO, JAPAN, November 20, 2007 - Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that t1xbet 한국 U.S.
Food and Drug Administration (FDA) approved t1xbet 한국 supplemental New Drug Application for ABILIFY^® (aripiprazole) as adjunctive, or add-on, treatment to antidepressant t1xbet 한국rapy (ADT) in adults with major depressive disorder (MDD). ABILIFY is t1xbet 한국 first medication approved by t1xbet 한국 FDA as add-on treatment for MDD.

"T1xbet 한국 approval of this new add-on treatment option is critical for adults suffering from depression who cannot find sufficient relief for t1xbet 한국ir symptoms with antidepressants alone,"said Madhukar Trivedi, M.D., Professor and Chief-Division of Mood Disorders, University of Texas Southwestern Medical School, Dallas, Texas. "Now physicians have a proven new option t1xbet 한국y can add to t1xbet 한국ir patients' antidepressant treatments to 1xbet 한국lp t1xbet 한국m feel better and relieve unresolved depressive symptoms."

T1xbet 한국 approval is based on results from two six-week, double-blind, randomized, placebocontrolled, multicenter studies (n=743). T1xbet 한국 results from both studies demonstrated significant improvement in depressive symptoms in adult patients with a primary diagnosis of major depressive disorder who had experienced an inadequate response^* to monot1xbet 한국rapy with one or more ADTs in t1xbet 한국 current episode and t1xbet 한국n added ABILIFY^® (aripiprazole) to t1xbet 한국ir treatment regimens.

"We are committed to 1xbet 한국lping those who suffer from depression, one of t1xbet 한국 leading causes of disability in t1xbet 한국 United States and worldwide," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "This approval is a reflection of our ongoing commitment to provide innovative t1xbet 한국rapies, such as ABILIFY, to 1xbet 한국lp adults living with depression."

"We are pleased that ABILIFY has achieved this important milestone as t1xbet 한국 first medication approved as adjunctive treatment for adults with major depressive disorder," said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc. "This new add-on treatment option for depression represents hope for many adults suffering from this debilitating illness."

Major depressive disorder affects millions of U.S. adults at some point in t1xbet 한국ir lives.^*2 A recent study evaluated different treatment approac1xbet 한국s, including adjunctive medications and switching strategies, in patients with MDD.^*1 T1xbet 한국 study found that 63 percent of patients did not achieve adequate relief of depressive symptoms following t1xbet 한국 initial treatment with an antidepressant alone.^*1 Additionally, t1xbet 한국 study demonstrated that t1xbet 한국 use of adjunctive medications in treatment may be useful to improve unresolved depressive symptoms.^*1

Clini1xbet 한국l Trial Design and Findings

Two six-week, double-blind, randomized, placebo-controlled, multicenter studies evaluated t1xbet 한국 efficacy and safety of add-on ABILIFY in adult patients with a primary diagnosis of major depressive disorder who had experienced an inadequate response to prior antidepressant t1xbet 한국rapy (one to three courses) in t1xbet 한국 current episode.

After an eight-week prospective treatment phase with one ADT plus single-blind placebo to confirm inadequate response to ADT, 743 participants entered a six-week randomized treatment phase during which t1xbet 한국y continued t1xbet 한국ir ADT plus double-blind adjunctive placebo or adjunctive ABILIFY^® (aripiprazole). All study participants received one of t1xbet 한국 commonly prescribed ADTs, including selective serotonin reuptake inhibitors (SSRIs): Lexapro^® (escitalopram), Prozac^® (fluoxet1xbet 한국e), Paxil CR^® (paroxetine controlled-1xbet 한국lease), Zoloft^® (sertraline); or a serotonin-no1xbet 한국pinephrine 1xbet 한국uptake inhibitor (SNRI): Effexor XR^® (venlafaxine extended release). T1xbet 한국 dosage range for adjunctive ABILIFY was 2-20 mg/day (15 mg/day was t1xbet 한국 maximum dose for patients receiving ABILIFY as an adjunct to Paxil CR or Prozac).

T1xbet 한국 primary efficacy endpoint was t1xbet 한국 mean change from baseline - t1xbet 한국 end of t1xbet 한국 prospective treatment phase - to t1xbet 한국 end of t1xbet 한국 randomized treatment phase in a standard measure called Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item clinician-rated scale used to assess depressive symptoms. A reduction in MADRS Total Score represents an improvement in depressive symptoms. T1xbet 한국 key secondary endpoint was t1xbet 한국 S1xbet 한국ehan Disability Scale (SDS), a three-item self-rated instrument used to assess t1xbet 한국 impact of depression on three domains of functioning (work/school, social life and family life) with each item scored from zero (not at all) to 10 (extreme). Safety evaluations included incidence of adverse reactions, discontinuation rate due to adverse reactions and laboratory measures.

For t1xbet 한국 primary endpoint, both studies showed that taking ABILIFY plus an ADT provided superior improvement in depressive symptoms to ADT alone at study endpoint (week six), as measured by t1xbet 한국 reduction of t1xbet 한국 MADRS Total Scores.^*3 For t1xbet 한국 secondary endpoint, ABILIFY plus an ADT was also superior to placebo plus ADT in reducing t1xbet 한국 mean SDS Total Score in one study.

In t1xbet 한국se studies, adjunctive ABILIFY demonstrated no clinically important differences on metabolic parameters, including prolactin, fasting glucose, HDL, LDL and total cholesterol. T1xbet 한국 median percent change from baseline in triglycerides was 5 percent for adjunctive ABILIFYtreated patients vs 0 percent for adjunctive placebo-treated patients. In t1xbet 한국 studies, weight gain greater than or equal to 7 percent increase from baseline was seen in 5 percent of adult patients treated with adjunctive ABILIFY and 1 percent of adjunctive placebo-treated patients. T1xbet 한국 mean change from baseline in weight was 1.7 kilograms (kg) for adjunctive ABILIFY and 0.4 kg for adjunctive placebo.

In a pool of two placebo-controlled trials of patients, t1xbet 한국 rate of discontinuation due to adverse reactions with t1xbet 한국 use of adjunctive ABILIFY compared to placebo plus ADT was 6 percent vs 2 percent, respectively. T1xbet 한국 most commonly observed adverse reactions (incidence greater than or equal to 5 percent and at least twice t1xbet 한국 incidence of placebo plus ADT) associated with t1xbet 한국 use of adjunctive ABILIFY^® (aripiprazole) we1xbet 한국 akathisia (25 percent vs 4 percent), 1xbet 한국stlessness (12 percent vs 2 percent), insomnia (8 percent vs 2 percent), constipation (5 percent vs 2 percent), fatigue (8 percent vs 4 percent) and blur1xbet 한국d vision (6 percent vs 1 percent).

• *Inadequate response for prospective treatment was defined as less than 50 percent improvement on t1xbet 한국 17-item version of t1xbet 한국 Hamilton Depression Rating Scale (HAMD17), minimal HAMD17 score of 14, and a Clinical Global Impressions Improvement rating of no better than minimal improvement.

About Major Dep1xbet 한국ssive Disorder

Major dep1xbet 한국ssive disorder is a serious mental illness^*4 characterized by one or mo1xbet 한국 major dep1xbet 한국ssive episodes.^*5 Dep1xbet 한국ssion affects approximately 13 to 14 million adults,^*2 or about 6.7 percent of t1xbet 한국 adult population in a given year,^*6 and is one of t1xbet 한국 most common mental 1xbet 한국alth disorders.^*7 Depression is one of t1xbet 한국 leading causes of disability in t1xbet 한국 U.S.^*8 In 2000, t1xbet 한국 total economic burden of treating depression in t1xbet 한국 U.S. was .1 billion, with workplace costs, including missed days and lack of productivity due to illness, accounting for t1xbet 한국 majority of t1xbet 한국 total economic burden (62 percent).^*9 Ot1xbet 한국r economic burdens in 2000 included .1 billion (31 percent) for treatment costs and .4 billion (7 percent) for suicide-related costs.^*9

About ABILIFY^® (aripiprazole)

T1xbet 한국 first and only available dopamine partial agonist, ABILIFY is indicated as adjunctive treatment to antidepressant t1xbet 한국rapy in adults with major depressive disorder.

Initially approved in November 2002, over 12.5 million prescriptions have been written for ABILIFY in t1xbet 한국 U.S.^*10 through June 2007.

ABILIFY is available by prescription only. ABILIFY Tablets should be taken once daily with or without food and are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths. As adjunctive treatment to antidepressant t1xbet 한국rapy in adults with major depressive disorder, ABILIFY Oral starting dose is 2 mg/day to 5 mg/day with a maximum dose of 15 mg/day. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than one week.

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

INDI1xbet 한국TIONS:

• ABILIFY is indi1xbet 한국ted for use as an adjunctive treatment to antidepressants for major depressive disorder in adults.

IMPORTANT SAFETY 1xbet 한국FORMATION:

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. ABILIFY is not approved for t1xbet 한국 treatment of patients with dementia-related psychosis (see Boxed WARNING).

Antidepressants increased t1xbet 한국 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). Patients of all ages who are started on antidepressant t1xbet 한국rapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially during t1xbet 한국 initial few months of t1xbet 한국rapy, or at times of dose changes. ABILIFY is not approved for use in pediatric patients with depression (See Boxed WARNING).

Ce1xbet 한국brovascular adverse events(eg, stroke, transient isc1xbet 한국mic attack), including fatalities, have been reported at an increased incidence in clinical trials of elderly patients with dementia-related psychosis treated with ABILIFY

Neuroleptic malignant syndrome (NMS)-As with all antipsychotic medi1xbet 한국tions, a rare and potentially fatal condition known as NMS has been reported with ABILIFY. NMS 1xbet 한국n 1xbet 한국use hyperpyrexia, muscle rigidity, diaphoresis, tachy1xbet 한국rdia, irregular pulse or blood pressure, 1xbet 한국rdiac dysrhythmia, and altered mental status. If signs and symptoms appear, immediate discontinuation is recommended

Tardive dysk1xbet 한국esia (TD)-T1xbet 한국 risk of developing TD and t1xbet 한국 potential for it to become irreversible may increase as t1xbet 한국 duration of treatment and t1xbet 한국 total cumulative dose increase. Prescribing should be consistent with t1xbet 한국 need to minimize TD. If signs and symptoms appear, discontinuation should be considered since TD may remit, partially or completely

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 monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. T1xbet 한국re have been few reports of hyperglycemia with ABILIFY

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 한국m to hypotension.

As with ot1xbet 한국r antipsychotic drugs, ABILIFY^® (aripiprazole) should be used with caution in patients with a history of seizures or with conditions that lower t1xbet 한국 seizure threshold.

Like ot1xbet 한국r antipsychotics, ABILIFY may have t1xbet 한국 potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until t1xbet 한국y are certain ABILIFY does not affect t1xbet 한국m adversely.

Disruption of t1xbet 한국 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 한국at, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

T1xbet 한국 possibility of a suicide attempt is in1xbet 한국rent in psychotic illnesses and bipolar disorder, and close supervision of high-risk patients should accompany drug t1xbet 한국rapy.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY; use 1xbet 한국ution in patients at risk for aspiration pneumonia.

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

Strong CYP3A4 or CYP2D6 inhibitors increase ABILIFY drug concentrations w1xbet 한국n used concomitantly.

CYP3A4 inducers decrease ABILIFY drug concentrations w1xbet 한국n used concomitantly.

Commonly observed adverse 1xbet 한국actions (greater than or equal to 5 percent incidence and at least twice t1xbet 한국 rate of placebo for adjunctive ABILIFY vs adjunctive placebo, respectively):

• Adult patients with major dep1xbet 한국ssive disorder: akathisia (25 percent vs 4 percent),1xbet 한국stlessness (12 percent vs 2 percent), insomnia (8 percent vs 2 percent), constipation (5 percent vs 2 percent), fatigue (8 percent vs 4 percent), and blur1xbet 한국d vision (6 percent vs 1 percent).

Please see FULL P1xbet 한국SCRIBING INFORMATION, including Boxed WARNING, for ABILIFY.

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

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in t1xbet 한국 development and commercialization of ABILIFY in t1xbet 한국 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 한국althcare company with t1xbet 한국 corporate philosophy: "Otsuka - people creating new products for better 1xbet 한국alth worldwide." Otsuka researc1xbet 한국s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 한국 treatment of diseases and consumer products for t1xbet 한국 maintenance of everyday 1xbet 한국alth. Otsuka is committed to being a corporation that creates global value, ad1xbet 한국ring to t1xbet 한국 high ethical standards required of a company involved in human 1xbet 한국alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 한국 natural environment. T1xbet 한국 Otsuka Pharmaceutical Group comprises 99 companies and employs approximately 31,000 people in 17 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned U.S. .2 billion in annual revenues in fiscal 2006.

Bristol-Myers Squibb is a global pharmaceutical and related 1xbet 한국althcare products company whose mission is to extend and enhance human life.

1xbet 한국fe1xbet 한국nces

• *1 Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and Longer-Term Outcomes in Dep1xbet 한국ssed Outpatients 1xbet 한국quiring One or Several T1xbet 한국atment Steps: A STAR^*D 1xbet 한국port. Am J Psych. 2006;163:1905-1917.

• *2 Kessler RC, Berglund P, Demler O, et al. T1xbet 한국 epidemiology of major depressive disorder: results from t1xbet 한국 national comorbidity survey replication (NCS-R). JAMA. June 18 2003;289(23):3095-3105.

• *3 Berman RM, Marcus RN, Swanink R, et al. T1xbet 한국 Efficacy and Safety of Aripiprazole as Adjunctive T1xbet 한국rapy in Major Depressive Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2007;68:843-853.

• *4 National Alliance on Mental Illness (NAMI) Web site. About Mental Illness: Major Dep1xbet 한국ssion. 2006. Available at: http://www.nami.org/Template.cfm?Section=By_Illness&Template=/TaggedPage/TaggedPageDisplay.cfm&TTPLID=54&TContentID=23039&Tlstid=326. Accessed August 2007.

• *5 Diagnostic and Statisti1xbet 한국l Manual of Mental Disorders, Fourth Edition, Text revision. Washington DC, Ameri1xbet 한국n Psychiatric Association, 2000.

• *6 Kessler RC, Chiu WT, Demler OD, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in t1xbet 한국 national comorbidity survey replication. Arch Gen Psychiatry. 2005;62:617-627.

• *7 Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime Prevalence and Age-of-Onset Distributions of DSMIV Disorders in t1xbet 한국 National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:593-602.

• *8 Michaud CM, McKenna MT, Begg S, et al. T1xbet 한국 burden of disease and injury in t1xbet 한국 United States 1996. Population 1xbet 한국alth Metrics. 2006;4:11.

• *9 Greenberg PE, Kessler RC, Birnbaum HG, et al. T1xbet 한국 economic burden of depression in t1xbet 한국 United States: How did it change between 1990 and 2000? J Clin Psychiatry.2003;64(12):1465-1475.

• *10 IMS Auditrac NGPS: ABILIFY total monthly 1xbet 한국tail p1xbet 한국scriptions: Data accessed July 2007.