FDA Approves New Epilepsy Drug

FDA approved Potiga tablets for seizures

June 14, 2011 / Author:  / Reviewed by: Joseph V. Madia, MD

Rate This Article

3.457145
0

(dailyRx News) The U.S. Food and Drug Administration has given the green light to a new Epilepsy drug that will aid with seizure control in adults.

Potiga (ezogabine) tablets were approved for use as an add-on medication to treat seizures associated with epilepsy in adults.

"Potiga can be used with other epilepsy medications."

The drug has been approved for treatment of partial seizures, the most common type seen in those with epilepsy, a brain disorder where there is abnormal or excessive activity in brain nerve cells. Partial seizures only affect a localized area of the brain, but can spread, and include symptoms such as spasms, convulsions with loss of consciousness and unusual behavior.

About a third of those with epilepsy are unable to achieve sufficient seizure control from their current treatment.

Potiga marks the first neuronal potassium channel opener for treating epilepsy. The drug acts as an anticonvulsant by reducing the excitability by stabilizing neuronal potassium channels in an “open” position.

Of the 1,000 adults participating in clinical trials for the drug, seizure frequency was reduced by up to 40 percent in those who responded favorably to the medication.

Common side effects reported in clinical trials include dizziness, fatigue, confusion, vertigo, tremors, problems with coordination, double vision, problems paying attention, memory impairment and lack of strength.

The drug also can cause urinary retention, or difficulty in emptying the bladder. Potiga may also cause neuro-psychiatric symptoms including confusion, hallucinations, and psychotic symptoms. Suicidal thoughts or actions could occur in a very small number of people.

The medication was developed by Valeant Pharmaceuticals North America of North Carolina, and will be distributed by GlaxoSmithKline. It is expected to be widely available by the end of the year.

Reviewed by: 
Review Date: 
June 13, 2011
Last Updated:
June 14, 2011