AMPYRA(达方吡啶缓释片)

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Ampyra获批用于提高多发性硬化症患者的步行速度
美国食品药品管理局（FDA）近日批准Ampyra缓释片用于提高多发性硬化症（MS）患者的步行速度。
MS是一种能够影响人类中枢神经系统——大脑、脊髓和视神经，从而致残的慢性疾病。MS的病程进展、严重程度和症状是不可预知的，并且不同患者的情况也可能会各不相同。有些患者的症状可能是轻度的，如四肢麻木；有些患者的症状可能是严重的，如麻痹或失明。FDA药品审评与研究中心神经病学产品部主任、医学博士Russell Katz说，“MS患者面对的最重要的问题之一是行走困难。”
临床试验显示，接受Ampyra治疗的患者步行速度比接受安慰剂治疗的患者步行速度更快。该药最常见的不良反应包括泌尿道感染、失眠、头晕、头痛、恶心、虚弱、背痛、平衡障碍、鼻咽肿胀、便秘、腹泻、消化不良、咽喉痛、发烧、注射部位麻刺感或瘙痒。当所用Ampyra剂量超过推荐剂量（10毫克，每天两次）时，可能会引起癫痫发作。患有中度或严重肾脏疾病的患者禁止使用Ampyra。

多发性硬化药Ampyra上市后销售良好
据Acorda Therapeutics公司公布的销售情况，Ampyra(dalfampridine)在上市后首个完整的季度内销售情况良好，销售额达到了2970万美元，高于此前分析师预测的1500万美元的销售额。公司表示很少的患者会因为不能报销的问题而不使用该药。
Ampyra(dalfampridine) 缓释片于2010年3月正式在美国上市用于提高多发性硬化症(MS)患者的步行能力。在美国多发性硬化症患者约有40万，在全球约有250万，行走困难是该药的一种最主要的症状之一。

Acorda申请延长Ampyra专利保护
生物技术公司Acorda Therapeutics Inc(ACOR)表示，已为其最近获准的多发性硬化症治疗药物Ampyra申请延长专利保护。
这家总部位于纽约Hawthorne的公司申请将两项专利的期限延长至多5年。这两项专利分别将于明年和2013年到期。如果获准，该公司将挑选其中一项被延长。
Acorda Therapeutics宣布，向美国专利商标局(PTO)提出申请，要求延长AMPYRA (daLFAmpridine)长效版药品10 mg的专利权保护期限，2010年1月22日FDA批准治疗多发性硬化症(MS)的AMPYRA上市，并且因为具有孤儿药资格，享有7年独卖期间。Acorda要求AMPYRA专利权
多发性硬化症影响人的脑部与神经系统，从而导致身体失衡、肌肉痉挛，以及其它行动问题。
今年1月，Ampyra获得了美国食品与药品管理局(FDA)的批准。FDA当时表示，该产品是首款获批准的帮助多发性硬化症患者行走的药物。FDA还警告称，如果使用超过推荐剂量，该药可能导致癫痫发作。
多发性硬化是一种慢性致残性自身免疫性疾病。据国际多发性硬化学会统计显示，在全世界范围内有超过250万人被诊断罹忠此病，其中仅美国就有40万患者深受其害。多发性硬化症的临床表现主要包括进行性行走困难，容易疲劳，身体协调性丧失以及视力、记忆力的下降，并伴有热敏感性。

What Is AMPYRA® (dalfampridine) Extended Release Tablets?
AMPYRA® (dalfampridine) Extended Release Tablets is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.
First in a new class of approved MS agents.
Shown to increase conduction through inhibition of potassium channels in animal studies. The mechanism by which AMPYRA (dalfampridine) exerts its therapeutic effect has not been fully elucidated.
AMPYRA improved walking speed in significantly more patients than placebo in 2 clinical trials (34.8% vs. 8.3% and 42.9% vs. 9.3%), p < 0.001 in both.
Improved walking in patients in two Phase 3 clinical trials:
Across the major types of MS.
With or without use of immunomodulatory drugs including interferons, glatiramer acetate, or natalizumab.
With no differences in effectiveness detected based on degree of impairment, age, gender or body mass index.
In EDSS scores ranging from 2.5 to 7.0.6
Oral administration

Indication
AMPYRA® (dalfampridine) Extended Release Tablets is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.

IMPORTANT SAFETY INFORMATION
The use of AMPYRA is contraindicated in the following conditions: History of seizure, or moderate or severe renal impairment.

AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.

Patients should discontinue use of any product containing 4-aminopyridine prior to initiating treatment with AMPYRA in order to reduce the potential for dose-related adverse reactions, including seizures.

Seizures: AMPYRA can cause seizures. The risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs.

Renally impaired patients: AMPYRA is contraindicated in patients with moderate or severe renal impairment (CrCl ≤ 50 mL/min); the risk of seizures in patients with mild renal impairment (CrCl 51-80 mL/min) is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating treatment with AMPYRA.

Urinary tract infections were reported more frequently as adverse reactions in patients receiving AMPYRA 10 mg twice daily compared to placebo.

The most common adverse events (incidence ≥ 2% and at a rate greater than the placebo rate) for AMPYRA in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.

The risk of adverse events, including seizures, increases with increasing AMPYRA doses. No additional benefit was demonstrated at doses greater than 10 mg twice daily.

There are no adequate and well-controlled studies of AMPYRA in pregnant women. AMPYRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Safety and effectiveness of AMPYRA in patients younger than 18 years of age have not been established.

Clinical studies of AMPYRA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

For more information, please see the complete Prescribing Information, including the Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA.