Potiga Approved by FDA to Treat Seizures in Adults
Potiga (ezogabine) has been approved by the U.S. Food and Drug Administration to treat seizures in adults with epilepsy.
The approval was given on June 10, 2011 for use of Potiga for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy.
Epilepsy is a disorder of the brain with many possible causes from illness to brain damage to abnormal brain development. In epilepsy there is abnormal or excessive neuronal (nerve cell) activity in the brain. This abnormal activity can lead to seizures.
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.
Antiepileptic drugs successfully prevent seizures in the majority of people who take them regularly and as prescribed, but as Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research note “About one third of people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using. 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.
Potiga is now a choice for treatment of partial seizures along with Carbatrol, Phenytoin, felbamate, Tiagabine, Levetiracetam, Pregabalin, and Topiramate.
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.
A less common adverse reaction to Potiga is urinary retention, or difficulty in emptying the bladder fully. Urinary retention will generally occur within the first six months of treatment if it does occur, although it can happen 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.