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Provides Another ABILIFY Formulation Option for Adults With Schizophrenia

or Manic Episodes of Bipolar I Disorder

    PRINCETON, N.J. and TOKYO, Aug. 17 /PRNewswire-FirstCall/ --
 Bristol-Myers Squibb Company (NYSE:   BMY) and Otsuka Pharmaceutical Co.,
 Ltd. today announced the launch of ABILIFY(R) DISCMELT(TM) (aripiprazole)
 Orally Disintegrating Tablets, a new oral form of the antipsychotic
 medication ABILIFY(R) (aripiprazole) that disintegrates rapidly in the
 mouth. The U.S. Food and Drug Administration (FDA) approved ABILIFY
 DISCMELT on June 7, 2006.
     ABILIFY DISCMELT provides a convenient alternative for adults with
 schizophrenia or manic episodes associated with Bipolar I Disorder.
 Pharmacokinetic studies showed that ABILIFY DISCMELT Orally Disintegrating
 Tablets are bioequivalent to regular ABILIFY tablets, thereby offering
 similar efficacy and safety at the same doses as the oral tablets.
     "Many adults with schizophrenia or Bipolar I Disorder, both in
 inpatient and outpatient settings, don't take their medication as
 prescribed," said John Zajecka, M.D., Director, Psychiatry Treatment
 Research Center and Associate Professor, Department of Psychiatry, Rush
 University Medical Center in Chicago. "ABILIFY DISCMELT provides healthcare
 professionals a formulation alternative that may be desirable for some
 adult patients."
     Some adults with schizophrenia or bipolar mania may have difficulty
 swallowing tablets or, in institutional settings, may hide pills inside
 their cheek to later spit them out. ABILIFY DISCMELT tablets are placed on
 the tongue and disintegrate rapidly upon contact with saliva, providing the
 convenience of a tablet without the need for liquid.
     The vanilla-flavored ABILIFY(R) DISCMELT(TM) (aripiprazole) 10 mg and
 15 mg Orally Disintegrating Tablets are packaged in blister packs and each
 dosage form is colored differently with scattered specks. Directions for
 use of ABILIFY DISCMELT Orally Disintegrating Tablets can be found in the
 FULL PRESCRIBING INFORMATION and should be shared with patients. Adults
 with phenylketonuria should be advised that ABILIFY DISCMELT contains
 phenylalanine.
     About ABILIFY
     The first and only available dopamine partial agonist,(1) 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. Since its initial
 approval in 2002, more than seven million prescriptions have been written
 in the United States.(2)
     ABILIFY is available by prescription only. ABILIFY tablets are
 available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 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. In addition to administration as
 a tablet, 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(R) (aripiprazole):
 
     Increased Mortality in Elderly Patients With Dementia-Related Psychosis
     Elderly patients with dementia-related psychosis treated with atypical
 antipsychotic drugs are at an increased risk of death compared to placebo.
 Although the causes of death were varied, most of the deaths appeared to be
 either cardiovascular or infectious in nature. ABILIFY(R) (aripiprazole) is
 not approved for the treatment of patients with dementia-related psychosis
 (see Boxed WARNING).
     ABILIFY is contraindicated in patients with a known hypersensitivity to
 the product.
     As with all antipsychotic medications, including ABILIFY, a rare
 condition referred to as neuroleptic malignant syndrome (NMS) has been
 reported. As with all antipsychotic medications, prescribing should be
 consistent with the need to minimize the risk of tardive dyskinesia (TD).
     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, including a significant dose response relationship in a
 fixed-dose trial. ABILIFY is not approved for the treatment of patients
 with dementia- related psychosis.
     Hyperglycemia, including some serious cases ranging from ketoacidosis,
 hyperosmolar coma, or death, has been reported in patients treated with
 atypical antipsychotics. Patients on ABILIFY should be appropriately tested
 before and monitored during treatment.
     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(R) (aripiprazole) 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.
     Patients should be advised to avoid alcohol while taking ABILIFY.
     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 reported with ABILIFY in 3-week
 bipolar mania trials at a greater than or equal to 5% incidence for ABILIFY
 and at a rate at least twice the rate of placebo include, respectively,
 akathisia (15% vs 4%), constipation (13% vs 6%), and accidental injury (6%
 vs 3%).
     Treatment-emergent adverse events reported with ABILIFY in short-term
 trials at an incidence greater than or equal to 10% and greater than
 placebo, respectively, include headache (31% vs 26%), agitation (25% vs
 24%), anxiety (20% vs 17%), insomnia (20% vs 15%), nausea (16% vs 12%),
 dyspepsia (15% vs 13%), somnolence (12% vs 8%), akathisia (12% vs 5%),
 lightheadedness (11% vs 8%), vomiting (11% vs 6%), and constipation (11% vs
 7%).
     The adverse events reported in a 26-week, double-blind schizophrenia
 trial comparing ABILIFY and placebo were generally consistent with those
 reported in the short-term, placebo-controlled schizophrenia trials, except
 for a higher incidence of tremor: 9% for ABILIFY vs. 1% for placebo.
     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
 in the United States and major European countries.
     ABILIFY(R) (aripiprazole) was discovered by 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-H0099   AC444540/05-06  August 2006
 
     References
 
     (1) Burris KD, Molski TF, XU C, et al. Aripiprazole, a novel
         antipsychotic, is a high-affinity partial agonist at human   dopamine
         D2 receptors. J Pharmacol Exp Ther. 2002;302:381-389.
 
     (2) IMS Auditrac NGPS: Abilify Total Monthly Retail Prescriptions: Data
         Accessed 04/24/2006.
 
 

SOURCE Bristol-Myers Squibb Company

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