美国FDA（美国食品和药物管理局）在2006年11月初核准一项植物性处方药Veregen™（茶多酚®英文），本产品的主要组成来自于绿茶萃取物，是一种局部外用的软膏，涂抹于患部，用以治疗人类乳突病毒（人类乳头状瘤病毒，人乳头瘤病毒）所引起的生殖器疣，是美国FDA核准的第一个植物性处方药。

根据美国FDA核准Veregen™仿单资料，本品主要组成Kunecatechins是从绿茶（茶树）茶叶中进行部份萃取而得，为含儿茶素（儿茶素）及其他绿茶成份的混合物。本产品主要是由两个随机，双盲，车辆控制的三期临床试验结果，作为其疗效及安全之支持证据，至于药效学及药理学方面并未如同化学药一样需要严谨的数据支持。

进行此两个临床试验的国家包括欧洲，美国及南美多个国家，招募接近400个患有生殖器疣或肛门疣的受试者。临床试验设计是针对18岁以上免疫功能正常的生殖器疣患者，治疗期间至16个星期或全部生殖器疣完全治愈为止，结果显示Veregen™的治愈率均高于车辆控制的对照组，因而获美国FDA核准上市。

本药品是由位于德国慕尼黑之MediGene公司生技公司所研发，在美国则由Bradley制药公司负责市场销售，该公司表示本产品将于2007年正式上市。MediGene公司针对生殖器疣，预估本天然药品每年约有一亿欧元的销售量，该公司总裁彼得海因里希表示对此药品在美国市场发展深具信心。

生殖器疣是一种常见且在全球快速扩散的性病，发生在生殖器及肛门附近的良性皮肤肿瘤，不但外形破损（耶稣基督），具感染性且不易治愈。在北美有1千4百万人，在欧洲约有1千5百万人因人类乳突病毒（HPV类型6或11））传染而患病。MediGene公司并表示该公司仍有多项肿疗相关候选药物正在研发中，他们拥有新药研发的创新平台技术。

虽然是美国FDA核准的第一个植物性处方药，但该药品的核准显然并未有太多的讨论及媒体的报导，但如同美国植物药协会（美国植物学会）创始人执行长马克布卢门撒尔对此事所发表的言论“，这是一个法规上重大突破...”“在超过半个世纪以来，首次植物药制剂以处方药上市的产品...”;植物性专家也是前美国FDA官员房地美安霍夫曼博士更直言：“一个新的产业即将诞生 - 或许在美国是“重生”“;”此核准案代表一个FDA的历史的里程卑，证明美国FDA已经知道如何处理植物药了，不再只是把它当成食品或膳食补充品，已经把它核准成药品了...
..“。

因此相信此药品获准上市，对近年来各国积极研发的植物药热潮更是注入一剂强心针，更可供国内植物药之研发及药政单位参考
      
布雷德利制药（BradleyPharmaceuticals）公司的植物药库内儿茶素（Kunecatechins，PolyphenonE）15％软膏（商品名：Veregen），用于治疗外生殖器和肛周疣，制剂专利2017年到期。此产品由医学基因（MediGene）公司开发，布雷德利制药公司在美国销售，计划2007年下半年上市。

PolyphenonE软膏内的活性成分是从绿茶提取的儿茶素精制混合物库内儿茶素，可有效地治疗一些人乳头瘤病毒（HPV）株感染的外生殖器和肛周疣。外生殖器疣是全球最常见和蔓延最快的性病。据估计，全球约有3000万人受此种HPV感染。目前治疗此种疾病主要以冷冻外科手术与咪喹莫特乳膏（商品名：Aldara）局部治疗相结合。PolyphenonE15％软膏是1997年Aldara上市以来治疗此种疾病的首个新品。

Veregen; (Polyphenon® E)

Manufacturer:
Doak and Kenwood
Pharmacological Class:
Botanical
Active Ingredient(s):
Sinecatechins 15%; oint.
      
Indication(s):
External genital and perianal warts (Condylomata acuminata) in immunocompetent patients ≥18yrs of age.
Pharmacology:
Veregen is a topical ointmentthatdeliverssinecatechins, a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze. Sinecatechins is a mixture of catechins and other components of green tea. Catechins comprise about 85–95% of the drug substance while the other components (gallic acid, theobromine, and caffeine) make up about 2.5%. The remainder of the drug substance contains undefined botanical constituents derived from green tea leaves.
The vehicle for Veregen is a water-free mixture that contains isopropyl myristate, white petrolatum, cera alba, propylene glycol palmitostearate, and oleyl alcohol.
Clinical Trials:
The safety and efficacy of Veregen was evaluated in two randomized, double-blind, vehicle-controlled studies in immunocompetent patients.
The median baseline number of warts was 6 (range 2–30).
The primary efficacy outcome measure was the response rate, defined as the proportion of patients who had complete clinical (visual) clearance of all warts (both baseline and new ones) by week 16. Subjects applied the ointment three times daily for up to 16 weeks or until complete clearance. Data was examined both for patients in the US only and for those in all countries in which testing occurred. For all countries, treatment with Veregen resulted in a complete clearance rate of 53.6%, compared to 35.3% for vehicle. For patients in the US alone, the response rates were 23.8% for Veregen and 0% for vehicle. When examined for efficacy by gender, 47.3% of males treated with Veregenhadcompleteclearance compared to 60.4% of females, while 28.8% of males using vehicle had a complete clearance, compared to 43.8% of females using vehicle. The median time to clearance was 16 weeks in one study and 10 weeks in the other. In patients with complete clearance, the rates of recurrence of warts 12 weeks after completion of therapy was 6.8% for those who had used Veregen compared with 5.8% for those who had used vehicle.
Legal Classification:
Rx
Adults:
≥18yrs: Wash hands. Apply ointment to each wart 3 times daily for up to 16 weeks. Do not cover treated area.
Children:
<18yrs: not recommended.
      
Precaution(s):
Do not use on internal or mucous membrane warts or on broken skin. Caution with tampon insertion(avoidinadvertent internal application). Wash ointment off if severe reaction occurs. Avoid sexual contact with ointment on skin. Immunosuppressed. May stain fabrics. Avoid sun, UV light on treated area. Pregnancy (Cat.C). Nursing mothers.
Interaction(s):
Concomitant use of condoms or diaphragm: notrecommended (ointment may weaken rubber).
Adverse Reaction(s):
Local reactions (eg, erythema, erosion, edema, itching, burning), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, rash, desquamation, bleeding, hypersensitivity, superinfection.
How Supplied:
Oint—15g, 30g

Last Updated:
1/14/2009