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Botox Maker Seeks Approval to Treat Strokes

Study finds drug eases spasticity in stroke patients

WEDNESDAY, Oct. 9, 2002 (HealthDayNews) -- Banishing the furrowed brow is not the only use for Botox.

It received approval for cosmetic use last April. But before that, the U.S. Food and Drug Administration (FDA) had approved Botox -- the brand name for a purified form of a protein called botulism toxin type A -- to relieve patients' suffering from eye and neck disorders.

Now its manufacturer, Allergan Inc., is seeking FDA approval to use Botox to reduce spasticity in patients suffering from stroke.

In the same way that Botox temporarily paralyzes the muscles that contract to form frowns in the forehead, it can relax the muscles of patients whose involuntary muscle contractions hinder their movement and cause them pain. This is called spasticity. Neurologists have been using the drug for this purpose for the last decade, despite the fact that it hasn't received the FDA's blessing for this use.

The FDA approves drugs for specific purposes, which are outlined on the labels, but doctors can legally use the drugs for other purposes if they think they are useful.

"It is an excellent drug because it can be used very specifically -- you can pinpoint the exact muscle as well as the exact dose -- and because it doesn't have side effects like dizziness, drowsiness and constipation that can come with other drugs, like valium," says Dr. Susan Pierson, a Cincinnati neurologist.

She has been using Botox to treat spasticity in patients for 12 years: "Most of the major insurers pay for it, including Medicare," she says.

Indiana University neurologist Dr. Allison Brasher is lead author of the most recent study on the benefits of Botox in reducing spasticity. The study, published in a recent issue of The New England Journal of Medicine, found that people with severe problems using their hands and fingers after a stroke were twice as likely to get relief from Botox injections than if they did not have Botox treatments.

"As a physician and investigator on the study, I hope the FDA will consider The New England Journal of Medicine study strong evidence that Botox should be approved for spasticity," she says. "It clearly has clinical meaningfulness, improving the quality of life for these patients."

In the study, half of the 126 stroke patients received injections of 240 units of Botox, 12 times more than the standard dose for wrinkles, and half received injections of a placebo.

Over the next 12 weeks, they were then asked to rate their improvement on one of four self-selected criteria: improvement in personal hygiene, dressing, limb position or pain. Sixty-two percent of those who were given Botox injections found relief of their symptoms, while only 27 percent of the patients taking the placebo reported improvement.

The study, which was funded by Allergan, is being included as part of the company's Phase II trials for approval by the FDA.

"We are just in the planning process to begin Phase III trials," says Nancy Grondhuis, of Allergan's scientific information and medical compliance department. She adds that FDA approval is at least several years away.

At the Drake Center, a rehabilitation and post-acute care hospital in Cincinnati, Pierson and her colleagues have successfully used Botox to reduce spasticity not only in stroke victims, but in patients with multiple sclerosis and in a man who was paralyzed from the neck down following a car accident.

Key to successful Botox therapy, however, Pierson says, is that the doctor be knowledgeable about which muscles to inject.

"The more complicated the clinical problem -- which means where the muscles are located in the body -- the more you need an experienced injector," she says.

What To Do

An explanation of Botox, what it does and its FDA-approved uses can be found at FDA. More information about Brashear's study can be found at Indiana University School of Medicine.

SOURCES: Susan Pierson, M.D., assistant clinical professor, neurology, University of Cincinnati, and neurologist, Drake Center, Cincinnati; Allison Brashear, M.D., associate professor, neurology, Indiana University School of Medicine, Indianapolis; Nancy Grondhuis, department of scientific information and medical compliance, Allergan Inc., Irvine, Calif.; August 2002 The New England Journal of Medicine
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