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FDA Approves Onfi to Treat Severe Type of Seizures10/24/2011
The U.S. Food and Drug Administration (FDA) approved Onfi tablets (clobazam) on October 21, 2011 for use as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older.
ONFI (pronounced "ON-fee") will be available in U.S. pharmacies in early January and is a federally controlled schedule four substance (C-IV).
"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 (LGS) usually begins when a child is 3-4 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. Patients commonly have frequent seizures of a wide variety, including tonic, atonic, absence and myoclonic. Most children with LGS experience some degree of impaired intellectual functioning or information processing, as well as developmental delays and behavioral disturbances. For more information on LGS, please click here.
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 the weekly frequency of drop seizures (atonic, tonic, or myoclonic seizures resulting in a fall or loss of posture) from the 4-week baseline period to a maintenance period. In both studies, patients taking Onfi had improved seizure control when compared to those taking control treatment (placebo in one study and low-dose Onfi in the other study).
Onfi is manufactured by Catalent Pharma Solutions LLC, Winchester, Ky., for Lundbeck Inc. of Deefield, Ill. The FDA is requiring that a Medication Guide be given to patients and caregivers when Onfi is dispensed. The Medication Guide describes the risks and adverse reactions people should be mindful of when using the product.
For more information on Onfi and its risks, side effects or adverse reactions, please read the FDA News Release or Lundbeck's Press Release.
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