- Otsuka-sponsored Study Evaluated Use of ABILIFY in Patients Ages 10 to 17
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TOKYO, Japan and PRINCETON, N.J., Nov. 15 /PRNewswire-FirstCall/ --
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 filing and granted a Priority Review to the supplemental New
Drug Application (sNDA) of the atypical antipsychotic ABILIFY(R)
(aripiprazole) for the treatment of pediatric patients (10 to 17 years old)
diagnosed with Bipolar I Disorder, manic or mixed episode with or without
psychotic features.
Priority Review status for an application or supplement for a drug
product is assigned if a product, if approved, could represent an
improvement compared to marketed products, including non-drug
products/therapies in the treatment, diagnosis or prevention of a disease.
The FDA goal for reviewing a drug with Priority Review is six months.
This sNDA is based on data from a multicenter, randomized,
double-blind, placebo-controlled study of two fixed oral doses of ABILIFY
(10 mg/day or 30 mg/day). The efficacy and safety of ABILIFY were assessed
in 296 ethnically diverse pediatric patients (ages 10 to 17) with Bipolar I
Disorder over a 30- week treatment timeframe, which consisted of a
four-week double-blind acute phase, followed by a 26-week double-blind
continuation phase. This trial was sponsored by Otsuka Pharmaceutical Co.,
Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development &
Commercialization, Inc. (Princeton, NJ) and was conducted at 54 centers in
the U.S.
About ABILIFY(R) (aripiprazole)
The first and only available dopamine partial agonist, ABILIFY is
indicated for the treatment of acute manic or mixed episodes associated
with Bipolar I Disorder in adults. ABILIFY is also indicated for the
treatment of schizophrenia in adults and adolescents (13 to 17 years old).
ABILIFY(R) (aripiprazole) Injection is indicated for the treatment of
adults with agitation associated with schizophrenia or Bipolar I Disorder,
manic or mixed.
Initially approved in November 2002, over 12.5 million prescriptions
have been written for ABILIFY in the U.S.(*1) 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. ABILIFY(R) DISCMELT(TM)
(aripiprazole) 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 and as a single-dose ready-to-use solution
for intramuscular injection 7.5 mg/mL. In adult patients, the recommended
ABILIFY Oral target dose is 15 mg/day to 30 mg/day in Bipolar I Disorder
and 10 mg/day to 15 mg/day in schizophrenia. In adolescent patients with
schizophrenia, the recommended ABILIFY Oral target dose is 10 mg/day (with
a starting dose of 2 mg/day which was titrated to 5 mg/day after 2 days and
to the target dose of 10 mg/day after 2 additional days). The 30 mg/day
dose was not shown to be more efficacious than the 10 mg/day dose. In adult
patients with agitation associated with bipolar mania or schizophrenia, the
ABILIFY Injection initial dose is 9.75 mg/1.3 mL. If ongoing ABILIFY
therapy is clinically indicated, oral ABILIFY in a range of 10 mg/day to 30
mg/day should replace ABILIFY Injection as soon as possible. The safety of
doses of ABILIFY Oral or ABILIFY Injection above 30 mg/day has not been
evaluated in clinical trials.
IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY
INDICATIONS:
-- ABILIFY is indicated for acute and maintenance treatment of
schizophrenia in adults
-- ABILIFY is indicated for the treatment of schizophrenia in adolescents
13 to 17 years of age
-- ABILIFY is indicated for acute and maintenance treatment of adults
with manic or mixed episodes associated with Bipolar I Disorder with
or without psychotic features
-- ABILIFY Injection is indicated for the treatment of adults with
agitation associated with schizophrenia or Bipolar I Disorder, manic
or mixed.
IMPORTANT SAFETY INFORMATION:
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 the treatment of patients with dementia-related
psychosis (see Boxed WARNING).
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
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
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.
Esophageal dysmotility and aspiration have been associated with
antipsychotic drug use, including ABILIFY; use caution in patients at risk
for aspiration pneumonia.
The possibility of a suicide attempt is inherent in psychotic illnesses
and bipolar disorder, and close supervision of high-risk patients should
accompany drug therapy.
Physicians should advise patients to avoid alcohol while taking
ABILIFY.
Strong CYP3A4 or CYP2D6 inhibitors increase ABILIFY drug concentrations
when used concomitantly.
CYP3A4 inducers decrease ABILIFY drug concentrations when used
concomitantly.
Commonly observed adverse events (greater than or equal to 5 percent
incidence and at least twice the rate of placebo for ABILIFY vs placebo,
respectively):
-- Adult patients with schizophrenia: akathisia (8 percent vs 4 percent)
-- Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal
disorder (17 percent vs 5 percent), somnolence (16 percent vs
6 percent), and tremor (7 percent vs 2 percent)
-- Adult patients with bipolar mania: constipation (13 percent vs
6 percent), akathisia (15 percent vs 3 percent), sedation (8 percent
vs 3 percent), tremor (7 percent vs 3 percent), restlessness
(6 percent vs 3 percent), and extrapyramidal disorder (5 percent vs
2 percent)
-- Adult patients with agitation associated with schizophrenia or bipolar
mania: nausea (9 percent vs 3 percent)
Please see FULL PRESCRIBING INFORMATION, including Boxed WARNING, for
ABILIFY.
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 global healthcare company with
the corporate philosophy: "Otsuka - people creating new products for better
health worldwide." Otsuka researches, develops, manufactures and markets
innovative and original products, with a focus on pharmaceutical products
for the treatment of diseases and consumer products for the maintenance of
everyday health. Otsuka is committed to being a corporation that creates
global value, adhering to the high ethical standards required of a company
involved in human health and life, maintaining a dynamic corporate culture,
and working in harmony with local communities and the natural environment.
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 U.S. $7.2 billion in annual
revenues in fiscal 2006.
Bristol-Myers Squibb is a global pharmaceutical and related healthcare
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 July 2007.
570US07PG40401
November 2007
0307N-0336
SOURCE Otsuka Pharmaceutical Co., Ltd.; Bristol-Myers Squibb
Company
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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,; 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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