Bristol-Myers Squibb Company And Otsuka Pharmaceutical Co., Ltd. Announce Availability Of 2 mg Abilify® (Aripiprazole) Tablet And Nonrefrigerated Oral Solution
Newly Available Options Equip Physicians with Increased Flexibility when Customizing Treatment to Address Specific Needs of Adults with Schizophrenia or Bipolar I Disorder
PRINCETON, NEW JERSEY AND TOKYO, JAPAN, February 7, 2006 -- Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. today announced two newly available options of Abilify® (aripiprazole) -- a 2 mg tablet strength and a nonrefrigerated oral solution (1 mg/mL). The Abilify 2 mg tablet equips physicians with an additional dosage strength to help them titrate patients to an effective dose. The nonrefrigerated oral solution formulation allows greater convenience for adults who are unable to swallow or have difficulty swallowing tablets.
Abilify is indicated for the treatment of schizophrenia, 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 weeks.i Abilify is the first and only available dopamine partial agonist.ii
“The availability of the Abilify 2 mg tablet is important for physicians because it allows us to better meet the specific dosing needs of adults with schizophrenia or Bipolar I Disorder,” said John Zajecka, M.D., director, Treatment Research Center, and associate professor of Psychiatry, Rush University Medical Center. “The nonrefrigerated oral solution gives physicians another choice when prescribing Abilify, which allows for more convenience and flexibility for adult patients.”
About Abilify® (Aripiprazole)
Abilify 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 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, nearly 6 million prescriptions have been written in the United States.iii
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.
It is important to talk to a health care provider for more information about Abilify. To learn more about Abilify, please visit www.abilify.com.
Full Abilify® (aripiprazole) Prescribing Information, including Boxed WARNING
IMPORTANT SAFETY INFORMATION FOR ABILIFY: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 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 (e.g., 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 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 (e.g., carbamazepine) could cause an increase in Abilify clearance and lower blood levels. Inhibitors of CYP3A4 (e.g., ketoconazole) or CYP2D6 (e.g., 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 percent incidence for Abilify and at a rate at least twice the rate of placebo include, respectively, akathisia (15 percent vs. 4 percent), constipation (13 percent vs. 6 percent) and accidental injury (6 percent vs. 3 percent).
Treatment-emergent adverse events reported with Abilify in short-term trials at an incidence greater than or equal to 10 percent and greater than placebo, respectively, include headache (31 percent vs. 26 percent), agitation (25 percent vs. 24 percent), anxiety (20 percent vs. 17 percent), insomnia (20 percent vs. 15 percent), nausea (16 percent vs.12 percent), dyspepsia (15 percent vs. 13 percent), somnolence (12 percent vs. 8 percent), akathisia (12 percent vs. 5 percent), lightheadedness (11 percent vs. 8 percent), vomiting (11 percent vs. 6 percent) and constipation (11 percent vs. 7 percent).
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 percent for Abilify vs. 1 percent for placebo.
INDICATIONS: Abilify is indicated for the treatment of:
# Schizophrenia, including maintaining stability in patients who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer and observed for relapse during a period of up to 26 weeks*
# Acute manic and mixed episodes associated with Bipolar I Disorder
# Maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least 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 patient.
Abilify is taken once daily with or without food.
Please see Full Abilify® (aripiprazole) Prescribing Information, including Boxed WARNING.
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 aripiprazole in the United States and major European countries.
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 81 companies and employs approximately 26,000 people in 16 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US $6.2 billion in annual revenues in fiscal 2004.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
Visit Otsuka Pharmaceutical Co., Ltd. at www.otsuka.co.jp
i Abilify (aripiprazole) Product Labeling, pg. 2.
ii 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.
iii Auditrac IMS Weekly NPA Plus; Month ending September 2005.
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