部分中文FAMPYRA处方资料（仅供参考）
Biogen Idec获准在澳洲销售FAMPYRA
Biogen Idec宣布，澳洲医药管理局核可销售FAMPYRA，药剂量为10 mg，改善多发性硬化症(MS)患者的走路能力。
CHMP建议有条件许可FAMPYRA
欧盟医药管理局(EMA)所属人用药品委员会(CMPH)推荐有条件许可FAMPYRA(R) (长效版fampridine 10 mg药丸)，改善多发性硬化症患者的走路能力。
fampridine缓释剂—慢性脊髓损伤的新药
fampridine缓释剂是4_氨基吡啶(4_AP)的一种缓释剂型，由Aeorda公司开发的，用于治疗慢性脊髓损伤(SCI)。该公司已开始了两项Ⅲ期临床试验，将在美国和加拿大的70家以上的SCI医疗中心共观察360例患者，用以评价该药在治疗与慢性SCI有关的中度至重度强直状态时的安全性及疗效。
fampridine(氨吡啶缓释制剂)能加强受损伤神经的传导，是第1个用来恢复SCI患者一些神经学功能的化合物。氨吡啶缓释制剂为一口服剂型，每天服2次。它能通过阻滞无髓鞘神经轴突暴露的钾通道而恢复神经传导功能。在一项双盲、安慰剂对照的试验中，10mg的氨吡啶缓释制剂能改善一些SCI患者的中枢性运动传导功能，这可能是该药使损伤部位的传导缺陷得以改善及增强了大脑皮层的兴奋性所致。
在一项开放标签、为期4周的试验中，对l6例慢性SCI患者评价了fampridine缓释剂多种口服剂量的药代动力学与安全性。患者在l周分别服用l0，l5，20或25mg(bid)。结果表明该药吸收较慢，于2．6～3．2h达到血浆峰值浓度，其平均血浆清除半衰期为5．5～7．5h。该药一般都能被患者良好耐受，且不良反应也都为轻中度，有2名患者因不良反应而停止用药。
对l3例长期存在SCI的患者和l3名志愿者的试验中，观察了单次口服10mg氨吡啶缓释制剂后的心率及其变化情况。结果发现基础心率较慢的SCI患者的心率变化能力低于志愿者，而服药后增加到对照组的水平。一项双盲、设平行组的试验证实，该药25mg(bid)被患者良好耐受，且能明显改善肠道功能及SubjectGlobal的印象计分。
对新生大鼠所做的一些实验显示，在神经损伤之前以氨吡啶缓释制剂处理运动神经末梢能预防运动神经元死亡。在碾压坐骨神经前3d以该药处理比目鱼肌和趾长伸肌能促进其神经支配的恢复，而未处理组则否。该药能以浓度依赖方式增加I型星形细胞、神经元和骨骼肌胞质中游离钙的浓度，并使钙进入星形细胞及肌肉细胞的量增高7倍，但对神经元无此作用。
总之，氨吡啶缓释制剂能改善慢性SCI或多发性硬化症患者的神经学功能。先前的一些临床试验已表明，该缓释剂能减轻强直状态，改善性功能及对肠道与膀胱的控制能力。

氨吡啶缓释剂—多发性硬化症治疗新药

椐美国研究显示，钾通道拮抗剂氨吡啶(fampridine SR)缓释制剂在多发性硬化(MS)患者的一个研究亚组中提示能改善患者行走能力。
在这项随机多中心试验中，206例多发性硬化患者接受氨吡啶缓释制剂10毫克(52例)，15毫克(50例)或20毫克(57例)，或者安慰剂，每日两次，共12周。研究发现，虽然氨吡啶缓释制剂各个剂量组患者平均行走速度都比安慰剂组有较大的改善，但没有一个达到显著性差异。然而，对参与超过3次治疗的患者进行事后分析发现，氨吡啶缓释制剂10毫克、15毫克及20毫克组中步行速度改善的患者比例均显著高于安慰剂组(分别为35.3%、36.0%及38.6%比8.5%)。
美国罗切斯特大学《柳叶刀》报道，口服氨吡啶缓释片治疗多发性硬化症的三期临床试验结果表明，氨吡啶(4-氨基吡啶)能改善多发性硬化征患者的运动功能。
这是一项随机、多中心、双盲对照的三期临床试验。301例多发性硬化症患者随机分为治疗组(氨吡啶10mg，每天两次，疗程14周;229例)和安慰剂组(72例)。结果测治疗前后25英尺步行时间，治疗组改善率(78/224，35%)高于对照组(6/72，8%;p<0.0001)；步速改善率治疗组(25.2%)也优于对照组(4.7%)。试验表明，氨吡啶能有效改善多发性硬化症患者的行走能力，减少患者卧床残疾，具有临床治疗意义。
氨吡啶缓释剂为一口服剂型，每天服2次。它能通过阻滞无髓鞘神经轴突暴露的钾通道而恢复神经传导功能，能以浓度依赖方式增加I型星形细胞、神经元和骨骼肌胞质中游离钙的浓度，并使钙进入星形细胞及肌肉细胞的量增高7倍，但对神经元无此作用。

Fampyra: new option for walking disability in MS
amFampyra (fampridine) is indicated for use in multiple sclerosis to improve walking in patients who have a walking disability (EDSS 4-7).

Recommended dose is twice a day, taken 12 hours apart, without food

PHARMACOLOGY

Fampridine is a potassium channel blocker. It prolongs channel repolarisation which enhances action potential formation in demyelinated axons, leading to improved neurological function.1

CLINICAL STUDIES

The efficacy of fampridine to improve walking was established in two double-blind studies in which patients with multiple sclerosis were randomised to receive prolonged-release fampridine 10mg twice daily or placebo. Completion of a timed 25-foot walk was used as the primary efficacy endpoint in both studies. Patients who showed a faster walking speed on at least 3 out of 4 occasions, in comparison to their walking speed before treatment, were considered to have responded to treatment.1,2
In one study (n=296), 34.8% of patients taking fampridine responded to the treatment, with an average increase in walking speed of 26.3% vs 5.3% on placebo (p<0.001). The other study (n=237) showed similar results with 42.9% responding to treatment and an increase in walking speed of 25.3% vs 7.8% (p<0.001).1-3

Treatment should be initiated and supervised by a specialist doctor experienced in the management of multiple sclerosis. Treatment should be limited to two weeks by which time any clinical benefits should have been identified. A timed walking test should be used to evaluate improvement after two weeks. If no benefits are observed, Fampyra should be discontinued.1
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What is Fampyra?
Fampyra is a medicine that contains the active substance fampridine. It is available as prolonged-release tablets (10mg).
What is Fampyra used for?
Fampyra is used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.
MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
The medicine can only be obtained with a prescription.
How is Fampyra used?
Treatment with Fampyra should be prescribed and supervised by a doctor experienced in MS. The recommended dose is one tablet taken by mouth, twice a day, 12 hours apart. The tablets should be taken without food.
Patients should be evaluated after two weeks and treatment should be stopped for those who have not shown an improvement.
Treatment should also be stopped if a patient’s walking ability worsens or if the patient does not report any benefit.
How does Fampyra work?
For the body’s muscles to contract, electrical impulses are transmitted along the nerves to the muscles. In MS, this transmission of electrical impulses is impaired when the protective sheaths around the nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.
The active substance in Fampyra, fampridine, is a potassium channel blocker. It acts on damaged nerves, where it prevents charged potassium particles from leaving the nerve cells. This is believed to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.
How has Fampyra been studied?
The effects of Fampyra were first tested in experimental models before being studied in humans. The company also used data from the scientific literature.
Two main studies were performed comparing Fampyra with placebo (a dummy treatment) in 540 patients with multiple sclerosis.
The patients were treated for nine or 14 weeks. The main measure of effectiveness was based on improvements in walking speed along a path of 25 feet (about 7.5 metres). Patients were considered to have responded to treatment if, on at least three out of four occasions, their walking speed was faster than their highest speed before treatment.
What benefit has Fampyra shown during the studies?
Fampyra was effective in improving walking speeds. In one of the main studies, around 35% of patients taking Fampyra responded to treatment compared with 8% of patients taking placebo. In the second study the results were similar with 43% of patients in the Fampyra group responding to treatment compared with 9% in the placebo group.
What is the risk associated with Fampyra?
The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness). The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection. For the full list of all side effects reported with Fampyra, see the package leaflet.
Fampyra should not be used in people who may be hypersensitive (allergic) to fampridine or any of the other ingredients. It must not be used with other medicines that contain fampridine or medicines known as ‘inhibitors of organic cation transporter 2’ such as cimetidine. It must not be used in patients who have seizures or have ever had seizures or in patients with kidney problems.
Why has Fampyra been approved?
The CHMP considered that Fampyra was likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment
can be identified at an early stage allowing treatment to be stopped in other patients. The Committee noted that no other
medicine was currently approved to treat the symptoms of MS and that the serious side effects with Fampyra were rare. The CHMP therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.
Fampyra has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, in particular on the medicine’s long-term effects on other aspects of walking ability. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
What information is still awaited for Fampyra?
The company that makes Fampyra will carry out a long term study on the effectiveness and safety of Fampyra. The study will look at the effects of Fampyra on other aspects of walking ability besides walking speed and will further investigate ways for the earlier identification of patients who respond to Fampyra earlier in order to guide further
treatment.Other information about FampyraThe European Commission granted a marketing authorisation valid throughout the European Union for Fampyra on 20/07/2011.
For more information about treatment with Fampyra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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产地国家: 欧洲共同体国家
原产地英文商品名:
FAMPYRA GRADUAL RELEASE RETARDTBL 10mg/tab 56tabs/box
原产地英文药品名:
FAMPRIDINE
中文参考商品译名:
FAMPYRA缓释片 10毫克/片 56片/盒
中文参考药品译名:
氨吡啶
生产厂家中文参考译名:
BIOGEN Idec GmbH
生产厂家英文名:
BIOGEN Idec GmbH
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产地国家: 欧洲共同体国家
原产地英文商品名:
FAMPYRA GRADUAL RELEASE RETARDTBL 10mg/tab 28tabs/box
原产地英文药品名:
FAMPRIDINE
中文参考商品译名:
FAMPYRA缓释片 10毫克/片 28片/盒
中文参考药品译名:
氨吡啶
生产厂家中文参考译名:
BIOGEN Idec GmbH
生产厂家英文名:
BIOGEN Idec GmbH