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Abbott's Depakote ER (Divalproex Sodium Extended-Release Tablets) Approved for Acute Manic or Mixed Episodes Associated With Bipolar Disorder

Extended-Release Formulation Offers Patients Conveniences of Once-Daily Therapy

ABBOTT PARK, IL -- December 6, 2005 -- Abbott announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for DepakoteŽ 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 DepakoteŽ (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, MD, 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% and at least twice as frequent as those seen with placebo were dyspepsia (23% vs. 11%), vomiting (13% vs. 5%) and abdominal pain (10% vs. 5%).

"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 DepakoteŽ ER
DepakoteŽ ER is the once-daily formulation of DepakoteŽ (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, 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% 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.


SOURCE: Abbott

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