ABILIFY(R) (Aripiprazole) Injection for Intramuscular Use for Adults With Agitation Associated With Schizophrenia or Bipolar Mania Now Available - Provides Rapid Control of Agitation -



    PRINCETON, N.J., and TOKYO, Dec. 12 /PRNewswire-FirstCall/ --
 Bristol-Myers Squibb Company (NYSE:   BMY) and Otsuka Pharmaceutical Co.,
 Ltd. today announced the launch of ABILIFY(R) (aripiprazole) Injection, an
 injectable form of ABILIFY, for intramuscular use. ABILIFY Injection
 provides rapid control of agitation in adults with schizophrenia or bipolar
 mania at primary endpoint (2 hours). The U.S. Food and Drug Administration
 (FDA) approved ABILIFY Injection on September 20, 2006.
     The urgent nature of acute agitation requires immediate assessment and
 intervention. ABILIFY Injection provides healthcare professionals with the
 first ready-to-use single-dose vial (9.75 mg/1.3 mL) of an atypical
 antipsychotic to calm the agitated patient.
     "Acute agitation can be very serious, distressing and potentially
 dangerous for patients, healthcare professionals and caregivers," said
 Michael H. Allen, MD, Director, Emergency Psychiatry, Associate Professor,
 University of Colorado at Denver and Health Sciences Center's School of
 Medicine. "ABILIFY Injection controls agitation independent of sedation."
     Acute Agitation
     Acute agitation is a common cause of psychiatric emergencies
 characterized by a range of behaviors that includes excessive motor and/or
 verbal activity, irritability, uncooperativeness, verbal outburst or abuse
 and threatening behavior or language.
     Smooth Transition from Injection to Oral Long-Term Therapy
     The Prescribing Information for ABILIFY(R) (aripiprazole) Injection
 instructs that if ongoing ABILIFY therapy is clinically indicated, ABILIFY
 Oral should replace ABILIFY Injection as soon as possible.
     Many physicians state that they would prefer to start with an
 injectable agent in the acute setting and then transition to the oral
 formulation of the same agent for long-term disease management. ABILIFY
 Injection now provides healthcare professionals with the ability to start
 and stay with ABILIFY in the treatment of schizophrenia or Bipolar I
 Disorder (manic or mixed). Physicians who elect to use ABILIFY for extended
 periods should periodically re-evaluate the long-term usefulness of the
 drug for the individual patient.
     Clinical Studies
     The efficacy of ABILIFY Injection in controlling acute agitation was
 evaluated in three short-term (24-hour), randomized, double-blind, placebo-
 controlled studies in patients with schizophrenia (two studies) and bipolar
 disorder (one study), manic or mixed, involving a total of 1,086 patients.
 The effectiveness of ABILIFY Injection to control agitation was measured in
 these studies using several scales, including the Positive and Negative
 Syndrome Scale Excited Component (PANSS EC) and Clinical Global Impression
 of Improvement (CGI-I) scale. The primary efficacy measure used for
 assessing signs and symptoms of agitation was the change from baseline in
 the PANSS EC at two hours post-injection. PANSS EC includes five items:
 poor impulse control, tension, hostility, uncooperativeness and excitement.
     ABILIFY Injection was statistically superior to placebo (p-value less
 than 0.05) in all three studies as measured using the PANSS EC. On the
 primary efficacy measure PANSS EC, the recommended dosage of 9.75 mg of
 ABILIFY Injection was shown to be effective in controlling agitation. In
 two studies in agitated patients with schizophrenia, ABILIFY(R)
 (aripiprazole) Injection and Haldol(R) (haloperidol) intramuscular, a
 common conventional antipsychotic frequently used for acutely agitated
 patients, were compared to placebo. These studies demonstrated that ABILIFY
 was superior to placebo. Haldol intramuscular, the active comparator, was
 superior to placebo.
     Clinical trial data also have shown that for agitated patients with
 schizophrenia who transitioned from ABILIFY Injection to ABILIFY 15 mg
 tablets, improvement was maintained.
     ABILIFY Injection and Ativan(R) (lorazepam) Injection, an antianxiety
 and sedative medication commonly used for the treatment of agitation, were
 compared to placebo in the study involving agitated patients with Bipolar I
 Disorder (manic or mixed). In this study, ABILIFY Injection was superior to
 placebo. Ativan Injection, the active comparator, was superior to placebo.
     The most frequently reported adverse events occurring in at least 5% of
 patients and greater than placebo with ABILIFY Injection were headache
 (ABILIFY 12% vs placebo 7%), nausea (ABILIFY 9% vs placebo 3%), dizziness
 (ABILIFY 8% vs placebo 5%), somnolence (ABILIFY 7% vs placebo 4%). In the
 three ABILIFY Injection trials, the safety profile was comparable to
 placebo regarding the incidence of Extrapyramidal symptoms (EPS), akathisia
 or dystonia. Non-akathisia related EPS adverse events were similar for the
 ABILIFY Injection and placebo groups (2% and 2%, respectively). The
 incidence of akathisia-related adverse events with ABILIFY Injection was 2%
 compared to 0% for placebo, while the incidence of dystonia with ABILIFY
 Injection was less than 1% compared to 0% for placebo. In addition, the
 incidence of QTc prolongation was also comparable between ABILIFY Injection
 and placebo.
     ABILIFY Injection is intended for intramuscular use only and is
 available in single-dose ready-to-use vials as a 9.75 mg/1.3 mL (7.5
 mg/mL), clear, colorless, sterile, aqueous solution. The recommended dose
 of ABILIFY Injection is 9.75 mg.
     ABILIFY now has one of the broadest ranges of formulations (tablets,
 non- refrigerated oral solution, orally disintegrating tablets and
 intramuscular injection) among antipsychotics to help support the
 individual needs of patients and their healthcare professionals.
     About ABILIFY
     The first and only available dopamine partial agonist, ABILIFY(R)
 (aripiprazole) is indicated for the treatment of schizophrenia including
 maintaining stability in adults who had been symptomatically stable on
 other antipsychotic medications for periods of three months or longer and
 observed for relapse during a period of up to 26 weeks. ABILIFY is also
 indicated for the treatment of acute manic and mixed episodes associated
 with Bipolar I Disorder, and for maintaining efficacy in adults with
 Bipolar I Disorder with a recent manic or mixed episode who had been
 stabilized and then maintained for at least six (6) weeks. Physicians who
 elect to use ABILIFY for extended periods should periodically re-evaluate
 the long-term usefulness of the drug for the individual. Initially approved
 in November 2002, ABILIFY is the fastest-growing atypical antipsychotic in
 the United States with over nine million prescriptions written through May
 2006.
     ABILIFY is available by prescription only. ABILIFY tablets are
 available in 2-, 5-, 10-, 15-, 20- and 30-mg strengths. The effective dose
 range is 10- 30 mg/day for schizophrenia patients and 15 or 30 mg/day for
 Bipolar I Disorder patients. ABILIFY DISCMELT(TM) Orally Disintegrating
 Tablets are available in 10 mg and 15 mg strengths. In addition, ABILIFY is
 available in a 1 mg/mL nonrefrigerated oral solution. The safety of doses
 of ABILIFY above 30 mg/day has not been evaluated in clinical trials.
     ABILIFY is taken once daily with or without food. It is important to
 talk to a healthcare professional for more information about ABILIFY.
     IMPORTANT SAFETY INFORMATION for ABILIFY:
     Elderly patients with dementia-related psychosis treated with atypical
 antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death
 compared to placebo (4.5% vs 2.6% respectively). ABILIFY is not approved
 for the treatment of patients with dementia-related psychosis (see Boxed
 Warning).
     -- 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. If signs and symptoms
        appear, immediate discontinuation is recommended
 
     -- Tardive dyskinesia (TD) -- The risk of developing TD and the potential
        for it to become irreversible may increase as the duration of treatment
        and the total cumulative dose increase. Prescribing should be
        consistent with the need to minimize TD.  If signs and symptoms appear,
        discontinuation should be considered since TD may remit, partially or
        completely
 
     -- Cerebrovascular adverse events (eg, stroke, transient ischemic attack),
        including fatalities, have been reported at an increased incidence in
        clinical trials of elderly patients with dementia-related psychosis
        treated with ABILIFY(R) (aripiprazole)
 
     -- 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.  There 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 them to
 hypotension.
     As with other antipsychotic drugs, ABILIFY should be used with caution
 in patients with a history of seizures or with conditions that lower the
 seizure threshold.
     Like other antipsychotics, ABILIFY may have the potential to impair
 judgment, thinking, or motor skills. Patients should not drive or operate
 hazardous machinery until they are certain ABILIFY does not affect them
 adversely.
     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 anticholinergic activity, or be subject to
 dehydration.
     As antipsychotics have been associated with esophageal dysmotility and
 aspiration, ABILIFY should be used cautiously in patients at risk for
 aspiration pneumonia.
     As the possibility of a suicide attempt is inherent in psychotic
 illness and bipolar disorder, close supervision of high-risk patients
 should accompany drug therapy. Prescriptions for ABILIFY should be written
 for the smallest quantity consistent with good patient management to reduce
 the risk of overdose.
     Physicians should determine if a patient is pregnant or intends to
 become pregnant while taking ABILIFY. Patients should be advised not to
 breast-feed while taking ABILIFY.
     Physicians should advise patients to avoid alcohol while taking
 ABILIFY(R) (aripiprazole).
     Both CYP3A4 and CYP2D6 are responsible for ABILIFY metabolism. Agents
 that induce CYP3A4 (eg, carbamazepine) could cause an increase in ABILIFY
 clearance and lower blood levels. Inhibitors of CYP3A4 (eg, ketoconazole)
 or CYP2D6 (eg, quinidine, fluoxetine, or paroxetine) can inhibit ABILIFY
 elimination and cause increased blood levels.
     Commonly observed adverse events (greater than or equal to 5% incidence
 and at a rate at least twice the rate of placebo for ABILIFY vs placebo,
 respectively):
     ABILIFY Oral
     In 3-week bipolar mania trials the following were reported: akathisia
 (15% vs 3%), constipation (13% vs 6%), sedation (8% vs 3%), tremor (7% vs
 3%), restlessness (6% vs 3%), and extrapyramidal disorder (5% vs 2%).
     In 4-6-week schizophrenia trials the following was reported: akathisia
 (8% vs 4%).
     A similar adverse event profile was observed in a 26-week trial in
 schizophrenia except for a higher incidence of tremor (ABILIFY 8% vs
 placebo 2%).
     ABILIFY Injection
     In short-term (24-hour) trials in patients with agitation associated
 with schizophrenia or bipolar mania the following was reported: nausea (9%
 vs 3%)
     Treatment-emergent adverse events reported with:
     ABILIFY Oral
     In short-term trials of patients with schizophrenia (up to 6-weeks) or
 bipolar disorder (up to 3-weeks) the following were reported at an
 incidence greater than or equal to 10% and greater than placebo,
 respectively, include headache (30% vs 25%), anxiety (20% vs 17%), insomnia
 (19% vs 14%), nausea (16% vs 12%), vomiting (12% vs 6%), dizziness (11% vs
 8%), constipation (11% vs 7%), dyspepsia (10% vs 8%), and akathisia (10% vs
 4%).
     ABILIFY Injection
     Treatment-emergent adverse events reported with ABILIFY Injection in
 short-term (24-hour) trials at an incidence greater than or equal to 5% and
 greater than placebo, respectively, include headache (12% vs 7%), nausea
 (9% vs 3%), dizziness (8% vs 5%), and somnolence (7% vs 4%).
     About Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.
     Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are
 collaborative partners in the development and commercialization of
 ABILIFY(R) (aripiprazole) in the United States and major European
 countries.
     ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. The brand
 name ABILIFY is registered to Otsuka Pharmaceutical Co., Ltd. Founded in
 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the
 mission statement: "Otsuka -- people creating new products for better
 health worldwide." Otsuka researches, develops, manufactures and markets
 innovative, original products, focusing its core businesses on
 pharmaceutical products for the treatment of disease and consumer products
 for the maintenance of everyday health. The Otsuka Pharmaceutical Group
 comprises 87 companies and employs approximately 27,000 people in 17
 countries and regions worldwide. Otsuka and its consolidated subsidiaries
 earned US $6.8 billion in consolidated annual revenues in fiscal 2005.
     Bristol-Myers Squibb is a global pharmaceutical and related health care
 products company whose mission is to extend and enhance human life.
             For more information and FULL PRESCRIBING INFORMATION,
                including Boxed WARNING, visit: www.abilify.com
                   Visit Bristol-Myers Squibb at: www.bms.com
        Visit Otsuka Pharmaceutical Co., Ltd. at: www.otsuka-global.com
 
    D6-H0102 December 2006 AC444668/09-06
 
 

SOURCE Bristol-Myers Squibb Company; Otsuka Pharmaceutical Co., Ltd.
RELATED LINKS
http://www.bms.com

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