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Vigabatrin Appears to Prevent Multiple Forms of Infantile Spasms: Presented at AES

By Ed Susman

SAN DIEGO, CA -- December 6, 2006 -- Infantile spasms, one of the forms of catastrophic epilepsy, appear to be controlled by treatment with vigabatrin, a drug widely available worldwide but not yet approved in the United States, researchers reported here at the 1^st North American Regional Epilepsy Congress (NAREC).

"Infantile spasms are diagnosed in about 2,000 children each year in the United States," said Roy Elterman, MD, specialist in pediatric epilepsy, Dallas Pediatric Neurology Associates, Dallas, Texas. He reported his results in children with cryptogenic, symptomatic-tuberous sclerosis and other symptomatic etiologies of infantile spasms.

"Vigabatrin was effective in rapidly producing freedom from spasms for symptomatic-other etiologies and tuberous sclerosis-induced infantile spasms," Dr. Elterman said in his poster presentation on December 3^rd.

In the study, 221 patients were treated with 2 doses of vigabatrin. The higher daily dose of 100 to 148 mg/kg proved to control the seizures more rapidly, compared with the low dose of 18 to 36 mg/kg, he said.

Patients with tuberous sclerosis form of spasms achieved freedom for seizures in an average of 3 weeks compared with 9 weeks for patients with cryptogenic form of the disease and 14 weeks for patients with other etiologies (P = .001).

"Data from this study suggest that vigabatrin may be considered as first-line treatment for all causes of infantile spasms," Dr. Elterman said.

Commenting on the study, Gregory Barkley, MD, clinical vice chairman of the department of neurology at Henry Ford Health System, Detroit, Michigan, said vigabatrin has an interesting history. Although approved elsewhere in the world and used for more than 2 decades in these serious cases of infantile epilepsy, the US Food and Drug Administration has twice declined to approve the drug.

However, doctors are still able to import the drug under special conditions, Dr. Barkley said. Dr. Barkley, a member of the board of directors of the American Epilepsy Society (AES), said his organization and others have sought re-consideration by the FDA.

Martin Brodie, MD, professor of medicine and clinical pharmacology, Western Infirmary, University of Glasgow, Scotland, United Kingdom, said vigabatrin appears to have some impact on visual fields of children who receive the drug for long-term treatment. That side effect has to be weighed against the drug's ability to thwart the seizures that, in young children, can have devastating consequences for mental and physical development.

Vigabatrin is being developed by Ovation Pharmaceuticals in hopes of bringing the drug to the market in the US.

The NAREC congress is a joint meeting of the American Epilepsy Society (AES), the Canadian League Against Epilepsy and the Jamaican chapter of the International League Against Epilepsy.


[Presentation title: Vigabatrin Effective in Multiple Etiologies of Infantile Spasms. Abstract 2.175]

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