It was announced on February 27, 2008 that the U.S. Food and Drug Administration (FDA) has accepted Ovation Pharmaceuticals’ new drug applications (NDA) for Sabril® (vigabatrin) in two types of epilepsies. The FDA assigned a priority NDA review for Sabril for the treatment of Infantile Spasms (IS), and will review the submission for refractory complex partial seizures (CPS) in the same time frame.

An NDA is the final step before the FDA decides whether or not to approve a medication for marketing. This application gives the FDA complete information on the history of the medicine, including details about clinical trials that have tested the medicine in patients. The time between filing of an NDA and approval of a new medicine for sale averages at least one year, as such, vigabatrin will not be immediately available in the US.

With regard to treatment of infantile spasms, there has been significant controversy as this relates to medication costs. (See related story at the end of this article.) Infantile spasms are characterized by a sudden jerk and then stiffening.

• Epilepsy.com: About infantile spams
• Epilepsy.com/Professionals: Infantile spasms constitute a unique and very serious epilepsy syndrome confined to infants.

Gregory L. Holmes, MD, Section Chief, Neurology, Dartmouth-Hitchcock Medical Center in New Hampshire, and a member of the epilepsy.com Editorial Board, is an expert on infantile spasms. With regard to the news about Sabril, he told epilepsy.com, “Vigabatrin is long overdue. It has been used in many other countries for many years. It is wonderfully effective in children with infantile spasms, particularly those children whose spasms are due to Tuberous Sclerosis. Although there are some concerns about retinal toxicity, the potential benefits far outweigh those risks. The drug will have to be used cautiously, but I think it will improve the lives of many of these children.”

Dr. Holmes added: "Visual function will need to be closely monitored by an ophthalmologist. In addition, a few children developed abnormal MRI scans while on the drug, and this will need to be monitored as well. The bottom line is that the epilepsy community will be extremely pleased since it is an effective drug for a very serious form of epilepsy. It is particularly welcomed at this time because of the extraordinarily high cost of the currently used medication, ACTH. If the FDA goes on to approve vigabatrin, it will be important for parents to consult with their neurologist to see if it is an appropriate choice for their child."

The full press release is available at: www.ovationpharma.com

Related Story:

• Drug Price Soars from $1,650 to $23,000 Per Vial To Treat Babies with Infantile Spasms: Parents and Physicians React

Edited by Steve C. Schachter, MD, February 29, 2008