Thursday, October 27, 2011

Epilepsy Drug Clobazam Approved By FDA

Epilepsy drug clobazam (Onfi) has been approved by the FDA for the treatment of a rare but severe form of epilepsy in adults and in children age two or older.

Dr. Russell Katz is the director of the division of neurology products in the agency's Center for Drug Evaluation and Research.

"Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures," Dr. Katz said in a written statement, Medpage Today reported.

"This is a difficult condition to treat, and it will be helpful to have an additional treatment option,” Katz added.

Onfi, manufactured for Lundbeck Inc. by Kentucky-based Catalent Pharma Solutions, has been on the market for years in other countries for treating anxiety and convulsions, Medpage Today reported.

Lennox-Gastaut, which typically begins before age four, can be caused by several conditions, including severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions.

It causes a variety of seizure types, including so-called tonic seizures (marked by stiffening of the body, upward movement of the eyes, pupil dilation, and altered breathing patterns).

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