Andi
12-12-05, 08:21 AM
ABBOTT PARK, Ill., Dec. 7 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT)
announced that the U.S. Food and Drug Administration (FDA) has approved a new
indication for Depakote(R) ER (divalproex sodium extended-release tablets) for
the treatment of acute manic or mixed episodes associated with bipolar
disorder, with or without psychotic features.
Depakote ER offers patients the convenience of taking this medication once
a day. Compared with Depakote(R) (divalproex sodium delayed-release tablets),
Depakote ER taken once a day helps provide more consistent levels of
medication in the body.
"Successful treatment for mania depends upon maintaining steady levels of
medication in the blood throughout the day," said Charles Bowden, M.D.,
professor of Psychiatry and Pharmacology, Department of Psychiatry, University
of Texas Health Science Center at San Antonio. "Depakote ER produces
consistent concentrations of medication throughout a 24-hour period. Depakote
has been trusted by psychiatrists for a decade, and this once-a-day
formulation is important for patients."
Approximately 2.3 million American adults have bipolar disorder, also
known as manic-depressive illness. Bipolar disorder is a brain disorder that
causes unusual shifts in a person's mood, energy and ability to function. The
symptoms of bipolar disorder can be severe. Symptoms of acute mania may
include, among others, abnormally elevated mood, irritability, marked increase
in energy, grandiose thinking and thought disorders. Mixed mania is a state
of mind characterized by symptoms of both mania and depression. Patients may
feel agitated, angry, irritable and depressed all at once. Like other serious
illnesses, bipolar disorder can have a negative impact on spouses, family
members, friends and the workplace. Depakote ER now provides a useful
treatment option for the acute manic and mixed episodes of bipolar disorder.
Depakote ER in Acute Mania Associated with Bipolar Disorder
The effectiveness of Depakote ER was confirmed in a randomized, double-
blind, placebo-controlled parallel group, three-week, multi-center study. The
primary efficacy measurement was the Mania Rating Scale (MRS) total score
evaluated on Day 21 as mean change from baseline to final evaluation (Day 21).
Depakote ER was significantly more effective than placebo in the reduction of
the MRS total score (mean change of -11.5 vs. -9.0 with placebo). The
approval of Depakote ER for the treatment of acute mania associated with
bipolar disorder was based in part on studies establishing the effectiveness
of Depakote.
In Depakote ER acute mania trials, adverse events with a frequency of
greater than 5 percent and at least twice as frequent as those seen with
placebo were dyspepsia (23 percent vs. 11 percent), vomiting (13 percent vs. 5
percent) and abdominal pain (10 percent vs. 5 percent).
"This expansion of the use of Depakote ER is another important step in
Abbott's commitment to developing innovative, effective and simpler treatments
for neurological and psychological disorders," said Eugene Sun, M.D., vice
president, Global Pharmaceutical Clinical Development at Abbott. "In addition
to our focus on bipolar disorder, Abbott scientists are investigating new
therapeutic approaches to depression, schizophrenia and cognitive disorders,
such as attention-deficit hyperactivity disorder and Alzheimer's disease."
About Depakote(R) ER
Depakote(R) ER is the once-daily formulation of Depakote(R) (divalproex
sodium delayed-release tablets), which has been a leading medication for the
treatment of mania associated with bipolar disorder since its approval in
1995. Depakote ER is also approved as monotherapy and adjunctive therapy in
the treatment of adults and children 10 years of age or older with complex
partial seizures that occur either in isolation or in association with other
types of seizures. Depakote ER is also indicated for use as sole and
adjunctive therapy in the treatment of simple and complex absence seizures in
adults and children 10 years of age or older, and adjunctively in adults and
children 10 years of age or older with multiple seizure types that include
absence seizures. Additionally, Depakote ER is approved for migraine
prevention in adults.
Important Product Safety Information for Depakote ER in Acute Mania
Valproate products should not be administered to patients with hepatic
disease or significant hepatic dysfunction. Hepatic failure resulting in
fatalities has occurred in patients receiving valproic acid and its
derivatives, usually during the first six months of treatment.
Valproate may produce teratogenic effects in the offspring of women
receiving the drug during pregnancy. Benefits of Depakote should be weighed
against risk of injury to the fetus in women of childbearing potential.
Cases of life-threatening pancreatitis, some rapidly progressing to death,
have been reported in both adults and children receiving valproate. Valproate
is contraindicated in patients with known urea cycle disorders (UCD), a group
of uncommon genetic abnormalities, due to reports of sometimes-fatal cases of
hyperammonemic encephalopathy. Concomitant administration of valproic acid
and topiramate has been associated with hyperammonemia with and without
encephalopathy.
The frequency of adverse effects, particularly elevated liver enzymes and
thrombocytopenia, may be dose-related. Multi-organ hypersensitivity reactions
have been reported after the initiation of valproate therapy. In a clinical
trial of valproate in elderly patients with dementia, some patients taking
valproate experienced somnolence, sometimes requiring discontinuation.
Common adverse events (greater than 5 percent incidence) associated with
Depakote ER or Depakote in clinical studies of acute mania patients were
somnolence, dyspepsia, nausea, vomiting, diarrhea, dizziness, pain, abdominal
pain, accidental injury, asthenia and pharyngitis.
About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs 60,000 people and markets its products in more than 130
countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com.
announced that the U.S. Food and Drug Administration (FDA) has approved a new
indication for Depakote(R) ER (divalproex sodium extended-release tablets) for
the treatment of acute manic or mixed episodes associated with bipolar
disorder, with or without psychotic features.
Depakote ER offers patients the convenience of taking this medication once
a day. Compared with Depakote(R) (divalproex sodium delayed-release tablets),
Depakote ER taken once a day helps provide more consistent levels of
medication in the body.
"Successful treatment for mania depends upon maintaining steady levels of
medication in the blood throughout the day," said Charles Bowden, M.D.,
professor of Psychiatry and Pharmacology, Department of Psychiatry, University
of Texas Health Science Center at San Antonio. "Depakote ER produces
consistent concentrations of medication throughout a 24-hour period. Depakote
has been trusted by psychiatrists for a decade, and this once-a-day
formulation is important for patients."
Approximately 2.3 million American adults have bipolar disorder, also
known as manic-depressive illness. Bipolar disorder is a brain disorder that
causes unusual shifts in a person's mood, energy and ability to function. The
symptoms of bipolar disorder can be severe. Symptoms of acute mania may
include, among others, abnormally elevated mood, irritability, marked increase
in energy, grandiose thinking and thought disorders. Mixed mania is a state
of mind characterized by symptoms of both mania and depression. Patients may
feel agitated, angry, irritable and depressed all at once. Like other serious
illnesses, bipolar disorder can have a negative impact on spouses, family
members, friends and the workplace. Depakote ER now provides a useful
treatment option for the acute manic and mixed episodes of bipolar disorder.
Depakote ER in Acute Mania Associated with Bipolar Disorder
The effectiveness of Depakote ER was confirmed in a randomized, double-
blind, placebo-controlled parallel group, three-week, multi-center study. The
primary efficacy measurement was the Mania Rating Scale (MRS) total score
evaluated on Day 21 as mean change from baseline to final evaluation (Day 21).
Depakote ER was significantly more effective than placebo in the reduction of
the MRS total score (mean change of -11.5 vs. -9.0 with placebo). The
approval of Depakote ER for the treatment of acute mania associated with
bipolar disorder was based in part on studies establishing the effectiveness
of Depakote.
In Depakote ER acute mania trials, adverse events with a frequency of
greater than 5 percent and at least twice as frequent as those seen with
placebo were dyspepsia (23 percent vs. 11 percent), vomiting (13 percent vs. 5
percent) and abdominal pain (10 percent vs. 5 percent).
"This expansion of the use of Depakote ER is another important step in
Abbott's commitment to developing innovative, effective and simpler treatments
for neurological and psychological disorders," said Eugene Sun, M.D., vice
president, Global Pharmaceutical Clinical Development at Abbott. "In addition
to our focus on bipolar disorder, Abbott scientists are investigating new
therapeutic approaches to depression, schizophrenia and cognitive disorders,
such as attention-deficit hyperactivity disorder and Alzheimer's disease."
About Depakote(R) ER
Depakote(R) ER is the once-daily formulation of Depakote(R) (divalproex
sodium delayed-release tablets), which has been a leading medication for the
treatment of mania associated with bipolar disorder since its approval in
1995. Depakote ER is also approved as monotherapy and adjunctive therapy in
the treatment of adults and children 10 years of age or older with complex
partial seizures that occur either in isolation or in association with other
types of seizures. Depakote ER is also indicated for use as sole and
adjunctive therapy in the treatment of simple and complex absence seizures in
adults and children 10 years of age or older, and adjunctively in adults and
children 10 years of age or older with multiple seizure types that include
absence seizures. Additionally, Depakote ER is approved for migraine
prevention in adults.
Important Product Safety Information for Depakote ER in Acute Mania
Valproate products should not be administered to patients with hepatic
disease or significant hepatic dysfunction. Hepatic failure resulting in
fatalities has occurred in patients receiving valproic acid and its
derivatives, usually during the first six months of treatment.
Valproate may produce teratogenic effects in the offspring of women
receiving the drug during pregnancy. Benefits of Depakote should be weighed
against risk of injury to the fetus in women of childbearing potential.
Cases of life-threatening pancreatitis, some rapidly progressing to death,
have been reported in both adults and children receiving valproate. Valproate
is contraindicated in patients with known urea cycle disorders (UCD), a group
of uncommon genetic abnormalities, due to reports of sometimes-fatal cases of
hyperammonemic encephalopathy. Concomitant administration of valproic acid
and topiramate has been associated with hyperammonemia with and without
encephalopathy.
The frequency of adverse effects, particularly elevated liver enzymes and
thrombocytopenia, may be dose-related. Multi-organ hypersensitivity reactions
have been reported after the initiation of valproate therapy. In a clinical
trial of valproate in elderly patients with dementia, some patients taking
valproate experienced somnolence, sometimes requiring discontinuation.
Common adverse events (greater than 5 percent incidence) associated with
Depakote ER or Depakote in clinical studies of acute mania patients were
somnolence, dyspepsia, nausea, vomiting, diarrhea, dizziness, pain, abdominal
pain, accidental injury, asthenia and pharyngitis.
About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs 60,000 people and markets its products in more than 130
countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com.