FDA批准依佐加滨辅助治疗癫痫

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　　6月10日，美国FDA批准依佐加滨（ezogabine）片剂用于成人部分性癫痫发作的辅助治疗，该药物是第一个治疗癫痫的神经元钾通道开放剂。
　　部分性癫痫是癫痫症最常见的一种类型，仅影响有限的或局灶性脑部区域，但可扩散至大脑其他部位。癫痫也可引发一系列症状，包括反复性肢体运动（抽筋）、异常行为和全身性无意识惊厥。
　　尽管，依佐加滨的作用机制并未完全阐明，该药可能通过稳定神经元钾通道使其保持“开放”状态、降低其兴奋性而产生抗惊厥作用。
　　依佐加滨最常被报告的不良反应包括头晕、疲劳、意识错乱、眩晕感、颤抖、协调问题、复视、注意力障碍、记忆力受损和乏力等。
　　在临床试验中，依佐加滨可引发尿储留或膀胱排空困难，因而服用该药的患者应当监测泌尿系统症状。
　　另外，依佐加滨可能引发神经-精神症状，包括意识错乱、幻觉和精神症状。上述症状通常会在停药1周内缓解。
　　与其他抗癫痫药相似，依佐加滨可能会升高**危险。如患者有**的想法或危险，患者应当立即咨询其健康医师有关**或死亡的想法、新的或加重的渴望或抑郁，或患者在其他行为或情绪上的异常变化。

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美国FDA信息
FDA approves Potiga to treat seizures in **s

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 **s.

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 ** or dying, new or worsened anxiety or depression, or other unusual changes in behavior or mood.

Potiga was approved with a Medication Guide that ***rms patients of the most important ***rmation about the medication. The guide will be distributed each time a patient fills their presc**tion.

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