- Otsuka-sponsored Study Evaluated Use of ABILIFY in Patients Ages 13-17 -
TOKYO and PRINCETON, N.J., JUNE 5 /PRNewswire/ -- Otsuka Pharmaceutical
Co., Ltd., and Bristol-Myers Squibb Company (NYSE: BMY) announced today
that the U.S. Food and Drug Administration (FDA) has accepted for priority
(six month review target) review the supplemental New Drug Application
(sNDA) of the atypical antipsychotic ABILIFY(R) (aripiprazole) for the
treatment of pediatric patients (13-17 years old) with schizophrenia. This
sNDA is based on data from a six-week, double-blind, randomized,
placebo-controlled study, sponsored by Otsuka Pharmaceutical Co., Ltd., and
its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization,
Inc. (Princeton, NJ) evaluating the use of ABILIFY in 302 ethnically
diverse pediatric patients (ages 13-17) and was conducted at 101 centers in
13 countries.
About ABILIFY(R) (aripiprazole)
The first and only available dopamine partial agonist, ABILIFY is
indicated for the short- and long-term 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. ABILIFY Injection
is indicated for the treatment of agitation associated with schizophrenia
or bipolar disorder, manic or mixed.
Initially approved in November 2002, over 10 million prescriptions have
been written for ABILIFY in the U.S.(1)through January 2007.
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. 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 non-refrigerated Oral Solution.
ABILIFY Injection, an injectable form of ABILIFY for intramuscular use,
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. The safety of doses of ABILIFY above 30 mg/day have 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 and INDICATIONS for ABILIFY
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*
ABILIFY Injection is indicated for the treatment of agitation
associated with schizophrenia or bipolar 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.
IMPORTANT SAFETY INFORMATION:
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
-- 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.
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- to 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: 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
In short-term (24 hour) trials, the following were reported at an
incidence greater than or equal to 5% and greater than placebo,
respectively: headache (12% vs 7%), nausea (9% vs 3%), dizziness (8% vs
5%), and somnolence (7% vs 4%).
Please see accompanying FULL PRESCRIBING INFORMATION, including Boxed
WARNING, for ABILIFY (aripiprazole).
About Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb
Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are
collaborative partners in the development and commercialization of ABILIFY
in the United States and major European countries.
ABILIFY 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 99 companies and employs approximately 31,000 people in 17
countries and regions worldwide. Otsuka and its consolidated subsidiaries
earned US $7.2 billion in consolidated annual revenues in fiscal 2006.
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: http://www.abilify.com
Visit Otsuka Pharmaceutical Co., Ltd. at: http://www.otsuka-global.com
Visit Bristol-Myers Squibb at: http://www.bms.com
(1)IMS Auditrac NGPS: Abilify total monthly retail prescriptions: Data
accessed 11/2006.
570US07PG18301 May 2007 0307N-0109
SOURCE Otsuka Pharmaceutical Co., Ltd.
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Related links:
http://www.abilify.com
http://www.otsuka-global.com http://www.bms.com
CONTACT:
Debra Kaufmann of Otsuka America
Pharmaceutical, Inc., +1-240-683-3568, debra.kaufmann@otsuka.com;
or Hideki Shirai of Otsuka Pharmaceutical Co., Ltd.,
+81-3-3292-0021, siraih@otsuka.jp; or David M. Rosen,
Communications, +1-609-252-5675, david.m.rosen@bms.com, or John
Elicker, Investor Relations, +1-212-546-3775,
john.elicker@bms.com, both of Bristol-Myers Squibb Company
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