Once-daily Depakote ER receives FDA approval for pediatric use

Once-daily Depakote ER receives FDA approval for pediatric use

ABBOTT PARK, ILL., September 9, 2003 -- Abbott Laboratories announced that the FDA has approved Depakote ER (divalproex sodium extended release) tablets for sole and adjunctive therapy to treat complex partial seizures in isolation or in association with other types of seizures and simple and complex absence seizures in children, ages 10 and above, with epilepsy.

Depakote ER is the once-daily formulation of Depakote (divalproex sodium delayed release) tablets, which has been a leading medication for the treatment of epilepsy since its initial approval in 1983. Depakote ER was approved for migraine prevention in adults in 2000 and for epilepsy in adults in 2002.

"Depakote ER improves seizure control in adult patients with epilepsy, and it's exciting that once-a-day dosing can now offer the same benefit to children with epilepsy," said John Pellock, M.D., professor of pediatrics and neurology, Virginia Commonwealth University, Medical College of Virginia. "In a pharmacokinetic study of Depakote ER in pediatric patients, the clinical researchers found that Depakote ER produces consistent, therapeutic concentrations of medication throughout an entire 24-hour cycle. I have also found that once-a-day dosing is much more convenient for children and their parents."

Approximately two million Americans have some form of epilepsy, with approximately 50 percent of newly diagnosed cases of epilepsy reported in children under age 18. Epilepsy is a chronic neurological condition that can result in periodic disturbances in the normal electrical functions of the brain, resulting in seizures, which are caused by unusually intense and intermittent electrical energy in the brain. Seizures can impact a person's consciousness, body movements or sensations for short periods of time.

"The approval of Depakote ER for use in pediatric patients demonstrates Abbott's commitment to addressing the needs of the wide range of patients with epilepsy," said Bill Dempsey, senior vice president, Pharmaceutical Operations, Abbott Laboratories. "Abbott continues to have an active research program in CNS disorders and is committed to developing the next generation of treatments for a variety of neurological disorders."

Study results

The pharmacokinetic profile and safety of Depakote ER was studied in a one-week open-label trial involving subjects between eight and 17 years of age. Subjects enrolled in the study were already taking Depakote delayed release tablets or Depakote ER tablets. All subjects were given doses of Depakote ER equivalent to their previous doses and were divided into two groups, one age eight to 11 (n=14) and the other age 12 to 17 (n=12). The pharmacokinetic profiles were compared with the profiles of a healthy adult historical control group.

The concentration-time profiles of Depakote ER were similar among the eight to 11 year olds and the 12 to 17 year olds, and the profiles did not differ significantly from the profile observed in the historical adult control group. The Depakote ER once-daily regimens were generally well tolerated. Adverse events reported by three or more subjects were flu syndrome (17 percent) and headache (10 percent).

In addition, Depakote ER once daily produced 40 to 50 percent lower peak- to-trough fluctuations compared to other valproate formulations requiring more frequent dosing. This behavior of Depakote ER in pediatric patients is similar to the performance of Depakote ER in adults.

The Depakote ER pediatric indication adds another convenient option in the versatile family of Depakote products for the treatment of complex partial and absence seizures, which includes Depakote, Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules), and Depacon (valproate sodium injection), an intravenous alternative. The once-daily Depakote ER formulation is available in both 250 mg and 500 mg tablets.

Important safety information

Depakote, Depakote ER (in adults and children), Depakote Sprinkle Capsules, and Depacon are indicated for the treatment of complex partial seizures and simple and complex absence seizures. Depacon is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible. Depakote and Depakote ER are also indicated for the prevention of migraine headaches in adults. 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 using Depakote and Depakote ER in migraine treatment 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. The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia, may be dose-related.

In a clinical trial of valproate in elderly patients with dementia, some patients taking valproate experienced somnolence, sometimes requiring discontinuation. The safety and effectiveness of Depakote and Depakote ER for the prevention of migraine patients over 65 years have not been established. The safety and effectiveness of Depakote ER for the prophylaxis of migraine headaches in pediatric patients has not been established. The safety and effectiveness of Depakote ER for the treatment of epilepsy has not been established in pediatric patients under the age of 10. Full prescribing information for Depakote, Depakote ER, Depakote Sprinkle Capsules and Depacon at www.depakote.com and www.depacon.com

Source: Abbott Laboratories www.abbott.com

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