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FDA NEWS RELEASE


For Immediate Release: June 13, 2011
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Potiga to treat seizures in adults

On June 10, Potiga (ezogabine) tablets were approved by the U.S. Food and Drug Administration for use as an add-on medication to treat seizures associated with epilepsy in adults.

Potiga was approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy. Epilepsy is a brain disorder in which there is abnormal or excessive activity of nerve cells in the brain. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain. Seizures cause a wide range of symptoms, including repetitive limb movements (spasms), unusual behavior, and generalized convulsions with loss of consciousness. 

“About one third of people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available for patients with epilepsy.”

Potiga is the first neuronal potassium channel opener developed for the treatment of epilepsy. Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an “open” position. 

The most common adverse reactions reported by patients taking Potiga in clinical trials included: dizziness, fatigue, confusion, spinning sensation (vertigo), tremor, problems with coordination, double vision, problems paying attention, memory impairment, lack of strength, and double-vision. 

Potiga can cause urinary retention, or difficulty in emptying the bladder fully. When urinary retention occurs, it is generally within the first six months of treatment, although it can also occur later. Because of the risk of urinary retention, urologic symptoms, such as the inability to start to urinate, weak urine stream, or pain with urination, should be carefully monitored. Urinary retention is a unique side effect among the medications used to treat seizures.  

Potiga may cause neuro-psychiatric symptoms, including confusion, hallucinations, and psychotic symptoms. When Potiga is discontinued, these symptoms usually resolve within seven days. 

Like other antiepileptic drugs, Potiga may cause suicidal thoughts or actions in a very small number of people. Patients should contact their health care professional right away if they have thoughts about suicide or dying, new or worsened anxiety or depression, or other unusual changes in behavior or mood. 

Potiga was approved with a Medication Guide that informs patients of the most important information about the medication. The guide will be distributed each time a patient fills their prescription. 

Potiga was developed by Valeant Pharmaceuticals North America of Durham, N.C., and will be distributed by GlaxoSmithKline of Research Triangle Park, N.C. 

For information: 

• National Institute of Neurological Disorders and Stroke, Epilepsy Information Page:

 Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 

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