英文药名: Dysport(Botulinum toxin type A)

中文药名: A型肉毒毒素注射剂

药品简介

美国Medicis公司（www.medicis.com）与法国Ipsen公司（www.ipsen.com）于4月30日联合宣布，Dysport（A型肉毒毒素）已获美国FDA同时批准治疗及美容适应症各一项：
1、颈部肌张力障碍；
2、眉间皱纹（中至中度，暂时改善，65岁以下）。
Medicis及Ipsen两家公司CEO均表示，此次Dysport获FDA同时批准治疗及美容适应症，是两家公司紧密合作的成果，并对Dysport在美国肉毒毒素美容市场的前景充满信心。
Dysport获准在美国上市，不仅对于Medicis及Ipsen两家公司具有重大意义，同时也正式终结了Botox（Allergan公司）垄断美国肉毒毒素美容市场的历史。
在此次FDA审批中，Dysport通过了专门的REMS安全性评估（Risk Evaluation and Mitigation Strategy）。这表明，Dysport的治疗功效大于其因毒素可能从注射区域游离而造成的潜在风险。同时，FDA要求Dysport在其包装中特别标注适用于所有肉毒毒素产品（包括Botox）的潜在毒素游离风险警告。
Dysport治疗用途产品将在2009年下半年在美国正式上市（由Ipsen负责），美容用途产品则将在1-2个月内在美国上市（由Medicis负责，经销商为北美第一大医药批发商McKesson）。有分析师认为，Dysport价格可能比Botox低约15%，有望在肉毒毒素美容市场侵占约1/3份额（至2012年，美容用途产品年销量可达1.6亿美元）。
2006年3月，Ipsen授权Medicis在美国、加拿大及日本研发、经销和商业化推广其肉毒毒素美容用途产品（Ipsen负责生产），协议有效期至2036年12月。据协议，Medicis应在Dysport获得FDA许可上市后（即现在）向Ipsen支付约7,500万美元，并在产品上市后根据销量和供货价格支付特许费（约合净销售额之30%）。（注：Medicis也是（自2004年）瑞典Q-Med透明质酸填充剂（Restylane、Perlane等）在北美的独家销售代理）

包装规格：
·500iu*1 vial支
·500iu*5vials支

Product Summary
Dysport®, botulinum toxin type A, has been available in the U.K. since the early 1990`s and has licences in 67 countries worldwide including the United Kingdom and many European markets. It is manufactured by the French company Ipsen.

The product is licensed for cosmetic use in a number of markets e.g. glabellar (frown) lines in Germany.

It also gained approval for cosmetic use in the UK in early 2009 and is marketed for this indication, with a dosing specific to treat glabellar lines,  under the brand name Azzalure® by Galderma.

Generic name
Clostridium botulinum type - A neurotoxin complex

How is it manufactured?
Dysport® is made from purified type - A neurotoxin produced by the bacteria Clostridium Botulinum.

How does it work?
It temporarily prevents the release of acetycholine from sympathetic nerve terminals.

Licenced status
Prescription only medicine

Who can administer the drug?
It should be used by trained members of the medical profession only.

Licenced UK indications
Dysport® is licenced in the UK for blepharospasm, hemifacial spasm, cervical dystonia, dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older; and focal spasticity, including the treatment of arm symptoms associated with focal spasticity, in conjunction with physiotherapy.

It can be used off-label for cosmetic use.

It also gained licensing for cosmetic use in the UK in early 2009 and is marketed for this indication, with a dosing (vial size) specific to treat glabellar lines,  under the brand name Azzalure®.

Who should not be treated?
Individuals with a known hypersensitivity to any component of the formulation.

Patients who have generalised disorders of muscle activity (e.g. myasthenia gravis).

Patients where aminoglycoside antibiotics or spectinomycin are already being used or are likely to be used.

Patients who have bleeding disorders of any type.

Pregnant or lactating women.

Reported side effects associated with cosmetic use include
Bruising or bleeding at the site of injection, headache, and rarely eyelid ptosis or diplopia, and brow droop.

Costs
Most clinics and practitioners charge by area of the face treated. These areas are usually defined as crow’s feet, forehead lines, and glabellar lines (frown lines between the eyes).