Finacea是十年来批准治疗酒渣鼻的首种新药

德国先灵制药公司的美国分公司布莱斯实验室宣布，ＦＤＡ已批准它们的Finacea（壬二酸）可以治疗轻、中度酒渣鼻的局部炎症性丘疹和脓疱。这是10多年来被批准用于酒渣鼻的第一种新药。
两个多中心、随机、双盲III期试验的结果表明，Finacea能明显减少酒渣鼻引起的炎症性丘疹和脓疱的数量，治疗4周就可见到效果，且在以后8周内效果还不断加强。2002年3月向ＦＤＡ提交的“新药申请” (NDA)介绍了这些结论。布莱斯公司皮肤病分部的副总裁和总经理克雷恩（Elise Klein）说，“这次批准是我们部门承诺在美国建立自己产品组合方面的重要里程碑”。他们希望能在2003年一季度让本药在美国上市。
Finacea含壬二酸，一种天然饱和二羧酸，是无色、无味的晶状物，不易在水中溶解，但能溶于酒精。Finacea的配方与膏状配方相比，渗透性更好。尽管该药的确切机制还不清楚，临床试验表明它能干扰酒渣鼻的致病因子，体外试验也发现有抗炎效应。适应症：轻、中度酒渣鼻的局部炎症性丘疹和脓疱。禁忌症和安全信息：有对丙二醇或本配方中的其它任何成份过敏史者慎用本药，它报告得最多的副作用有烧灼感/麻刺感和发痒，见于10%的病人。还有1-10%的病人皮肤发干，有皮疹。多数副作用均很轻微。
美国有1,300万酒渣鼻患者，年龄30-50岁，但医生估计实际患者更多。许多病人自己不知道有本病，因此也没在早期阶段寻治。

What is Finacea?
FINACEA is a prescription gel that you apply to your skin twice every day. It is safe and effective for treating both the bumps and lesions and the redness of mild to moderate rosacea.
Finacea is light, easily absorbed, and is most often prescribed by dermatologists. In fact, FINACEA is prescribed primarily by dermatologists and it is considered by them to be a first-line treatment option for rosacea sufferers.
FINACEA is unique. Here are a few of its key features:
FINACEA is the first prescription gel approved by the FDA for treating the redness and the bumps and pimples associated with rosacea.
It contains azelaic acid, a naturally occurring active ingredient that is present in whole grains and in the skin.
It can be used in conjunction with non-irritating skin care products and cosmetics. It's a water-based gel that is fragrance-free (to help prevent allergic reactions), alcohol-free (to help prevent irritation and dryness), easily absorbed, and that penetrates deeply. It's perfect for daily use at home and on the go.

Unlike some topical medications whose effectiveness levels off after 8 weeks, in a medical trial, rosacea sufferers using FINACEA experienced a continuous decline in red bumps and pimples throughout 12 weeks of treatment.

Finacea is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Finacea is for dermatologic use only, and not for ophthalmic, oral, or intravaginal use. Finacea is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. In clinical trials, sensations of burning/stinging/tingling occurred in 29% of patients, and itching in 11%, regardless of the relationship to therapy. Post-marketing safety—Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure to the eye. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation.

英文药名: Finacea (Azelaic Acid Topical Gel)

中文药名: 壬二酸外用凝胶

商品名: FINACEA
成分品名: AZELAIC ACID
中文译名: 非娜丝
Finacea（壬二酸）已经被ＦＤＡ批准可以治疗轻、中度酒渣鼻的局部炎症性丘疹和脓疱。试验结果表明，Finacea能明显减少酒渣鼻引起的炎症性丘疹和脓疱的数量，治疗4周就可见到效果，且在以后8周内效果还不断加强。
Finacea含壬二酸，一种天然饱和二羧酸，是无色、无味的晶状物，不易在水中溶解，但能溶于酒精。Finacea的凝胶配方与膏状配方相比，渗透性更好。临床试验表明它能干扰酒渣鼻的致病因子，体外试验也发现有抗炎效应。
适应症：轻、中度酒渣鼻的局部炎症性丘疹和脓疱。
禁忌症：有对丙二醇或本配方中的其它任何成份过敏史者慎用本药，它报告得最多的副作用有烧灼感/麻刺感和发痒，见于10%的病人。还有1-10%的病人皮肤发干，有皮疹。多数副作用均很轻微。