Magazine article Drug Topics

Felbatol Approval Launches 'New Era' in Epilepsy Therapy

Magazine article Drug Topics

Felbatol Approval Launches 'New Era' in Epilepsy Therapy

Article excerpt

In the last days of July, the Food & Drug Administration did something it hasn't done since Jimmy Carter was president: It approved a new compound for the treatment of patients with epilepsy.

Wallace Laboratories' Felbatol, or felbamate, is the first of three antiepileptics recommended for approval to get the official go ahead. At press time, New Drug Applications were still pending for Warner-Lambert Co.'s Neurontin (gabapentin) and Burroughs Wellcome Co.'s Lamictal (lamotrigine).

"There hasn't been a major new epilepsy drug in over 15 years," Denise Malkowicz, an epileptologist and neurologist at the Medical College of Pennsylvania's Mid-Atlantic Regional Epilepsy Center told listeners at a recent press conference in Washington, D.C. That, she remarked to those gathered in the National Press Club Ballroom, is "a half of a lifetime, or a lifetime for some of my patients."

Felbatol is indicated for the treatment of patients aged 14 and older who suffer partial onset seizures with or without generalized seizures. The drug may be used as monotherapy or as an "add-on" treatment.

In addition, Felbatol is approved for use as an adjunctive therapy in children aged 2 years and older who have Lennox-Gastaut syndrome. Lennox-Gastaut is "one of the most severe forms of epilepsy," explained W. Edwin Dodson, professor of pediatrics and neurology at Washington University School of Medicine, in St. Louis, Mo. The disorder begins in early childhood and is characterized by multiple seizure types, including atonic seizures or "sudden drop attacks" that cause young patients to fall unexpectedly.

All in all, it is estimated that between 500,000 and 700,000 of the 2.5 million Americans with epilepsy are inadequately treated, Dodson said. Such patients endure either uncontrolled seizures, excessive drug-related adverse reactions, or a combination of the two.

"For most patients and their physicians, treating epilepsy up to this point has meant a series of compromises--trying to make the best of what is available and cope with the unwanted side effects," Malkowicz said.

Treatment can often mean "walking a fine line between seizures and toxicity," she continued. Many patients learn to live with adverse reactions like cognitive impairment, depression, behavioral changes, slurred speech, tremors, and cosmetic problems, including weight gain, hair loss, gum overgrowth, and coarsening of facial features.

Or, Malkowicz noted, "patients and their physicians choose to live with a certain number of seizures rather than experience the nearly continuous problems with medication side effects." She pointed out that this route can be a risky business, as patients are sometimes injured in the course of a seizure.

A 'new era': "Fortunately, we are beginning to look forward to a new era in antiepilepsy drug therapy; one that promises to offer seizure control without compromise in quality of life," Malkowicz said. "Felbamate is a unique drug, in that it both controls seizures and produces fewer, and less troubling, adverse reactions than other medications currently available."

Clinical studies involved 50 academic centers, more than 200 investigators, and some 2,000 patients with epilepsy, Dodson said. Trial participants were patients with intractable epilepsy who were undergoing evaluation for possible surgical treatment, outpatients who experienced a minimum of four partial seizures per month, and children with Lennox-Gastaut, who had at least 90 seizures per month. …

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