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.
Bristol-Myers Squibb Company
bms
View drug information on Abilify.
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