Jan. 22, 2010 - The FDA has approved Ampyra (dalfampridine), which improves walking ability in adults with multiple sclerosis (MS).

About three-fourths of MS patients have trouble walking, and 70% of those with walking problems say this is the most challenging aspect of their disease.

Ampyra is taken with other MS drugs and does not keep MS from getting worse, says Andrew D. Goodman, MD, director of the MS center at the University of Rochester, N.Y. Goodman led some of the clinical trials that led to the drug's approval.

"A large segment of people with MS have difficulty walking, and we have found that it helps some patients -- 35% in one study and 42% in another -- to consistently walk faster," Goodman tells WebMD. "Among those who do walk faster, they improve about 25% from baseline. These patients said they could walk longer distances, be on their feet longer, climb stairs better, and better perform other walking functions."

Ampyra does not change the course of MS disease, but enhances nerve function.

"There is no indication this type of treatment slows the progressive nature of the disease process," Goodman says. "But there is every indication that at whatever level of function an MS patient may have, there may still be room for improvement with this type of treatment."

The drug is by no means risk-free. Ampryra is a new formulation of a drug called fampridine, which was originally used as a bird poison.

Some 20 years ago, test tube studies suggested that fampridine could improve nerve conduction. Since then, some neurologists -- Goodman is not one of them -- have ordered the drug from compounding pharmacies for their MS patients.

At doses higher than the approved dose -- 10 milligrams twice daily -- Ampyra can cause seizures. The drug cannot be used by MS patients with a history of seizure, or by those with moderate-to-severe kidney disease. The drug cannot be taken with other forms of fampridine.

Side effects seen in clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, back pain, loss of muscle strength, balance disorder, multiple sclerosis relapse, tingling or numbness in the extremities, nose or throat inflammation, constipation, upset stomach, and throat pain.

Ampyra,dalfampridine缓释片

0 - 美国FDA已经批准Ampyra（dalfampridine），改善了走在多发性硬化症（MS）的成人的能力。

约四分之三的MS患者走路有困难四分之三，并与70％的人走路的问题说这是他们的疾病的最具挑战性。

Ampyra采取与其他MS药品和微软并没有恶化，说安德鲁D古德曼博士的MS中心主任在罗切斯特大学，纽约古德曼带领导致药物的临床试验批准一些。

“一个人与微软的很大一部分走路有困难，我们发现，它有助于在一项研究中一些病人 - 35％，另外42％ - 坚持走路快，”古德曼告诉中央社。在那些谁做“走得快，他们提高约25％的基准。这些患者说，他们可以走更远的路，在他们的脚更长，爬楼梯更好，更好地履行其他行走功能。”

Ampyra不会改变的MS病程，但神经功能增强。

“没有迹象表明这种类型的治疗减缓疾病的进程的先进性，”古德曼说。 “不过，种种迹象表明，在任何功能的MS病人可有水平，但仍然可以治疗这种类型的改进的余地。”

这种药物并非无风险。 Ampryra是一个药物名为fampridine新的提法，它最初是作为一种鸟毒药使用。

大约20年前，试管中的研究显示，fampridine可以改善神经传导。自那时以来，一些神经学家 - 古德曼不是其中之一 - 已下令从复利的多发性硬化症患者的药房的药物。

在剂量超过核准剂量更高 - 10毫克，每日2次 - Ampyra可导致癫痫发作。这种药物不能使用的MS病人中检获的历史，或中度至重度肾脏疾病者。这种药物不能与fampridine采取其他形式。

在临床试验中出现的副作用包括尿路感染，失眠，头晕，头痛，恶心，背痛，肌肉力量，平衡障碍，多发性硬化症复发刺痛或四肢，鼻子或喉咙发炎，便秘，麻木，胃部不适损失，和咽喉疼痛。

Ampyra是阿索尔达霍桑的治疗进展，纽约阿索尔达说，药物应在美国上市3月

Ampyra approved to improve walking in multiple sclerosis patients

The FDA has approved Ampyra (dalfampridine extended-release tablets, from Elan and Acorda Therapeutics) to improve walking in adults with multiple sclerosis (MS). Ampyra exerts its effects by closing the exposed potassium channels on demyelinated axons which cause nerve impulse “short circuits”, subsequently improving nerve impulse conduction. In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with placebo.