SILVER SPRING, Md., Oct. 24, 2011 /PRNewswire-USNewswire/ -- On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA.
"Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "This is a difficult condition to treat, and it will be helpful to have an additional treatment option."
Lennox-Gastaut syndrome usually begins before 4 years of age, and can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions. In 30 to 35 percent of patients, no cause can be found. Patients commonly have frequent seizures of a wide variety, including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks).
Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, as well as developmental delays and behavioral disturbances.
The effectiveness of Onfi, when added to ongoing seizure medication, was established in two multicenter controlled studies of patients 2 years of age and older. In each study, the drug was tested for the amount of reduction in
|SOURCE U.S. Food and Drug Administration|
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