Pharmacological Class:
Topical antiviral + anti-inflammatory.
Active Ingredient(s):
Acyclovir 5% + hydrocortisone 1%; crm.
Indication(s):
For the early treatment of recurrent herpes labialis (cold sores), to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (≥12 years of age).
Pharmacology:
This product combines the antiviral agent, acyclovir, with the anti-inflammatory corticosteroid, hydrocortisone. Acyclovir is a synthetic purine nucleoside analogue with inhibitory activity against herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase encoded by HSV. Hydrocortisone is used topically for its anti-inflammatory properties that suppress the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.
Clinical Trials:
A double-blind study involving 1443 adult patients with recurrent herpes labialis was conducted to assess the efficacy of this product in reducing the number and severity of cold sore outbreaks. In the previous 12 months, the patients had an average of 5.6 episodes of herpes labialis. The median age of these patients was 44 years (range 18 to 80 years), 72% were female, and 91% were Caucasian. They were randomized to be treated with Xerese, acyclovir 5% in vehicle, or vehicle alone. Patients were instructed to start treatment within 1 hour of noticing signs and symptoms, to apply the product 5 times daily, and to continue treatment for 5 days. Fifty-eight percent of the patients using Xerese experienced ulcerative cold sores, compared to 74% of those using vehicle alone and 65% using acyclovir + vehicle. The mean time to skin normalization was about 1.6 days shorter in patients randomized to Xerese compared to vehicle. In addition, clinical signs (eg, size of cold sore, tenderness) were reduced with Xerese compared to vehicle.
An open-label study involving 134 adolescents with recurrent herpes labialis was conducted to assess the safety of Xerese. In the previous 12 months, these patients had an average of 4 episodes of herpes labialis. All subjects were Caucasian with a median age of 14 years (range 12 to 17 years) and 50% were female. The treatment and dosing regimen of Xerese were the same as in the adults study; and subjects were monitored for adverse events and selected efficacy parameters. At the end of treatment, the study demonstrated that the safety and efficacy were similar to that observed in adults.
Legal Classification:
Rx
Adults:
Start as soon as possible after the first signs and symptoms emerge (ie, during the prodrome or when lesions appear). Wash and dry area. Apply topically to affected area on lips or around the mouth 5 times daily for 5 days. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Do not occlude. Wash hands before and after application; wait at least 30min before bathing, showering, or swimming.
Children:
Not recommended.
Warnings/Precautions:
Immunocompromised. Reevaluate if symptoms persist more than 2 weeks. Avoid eyes, inside the mouth or nose, or on the genitals. Pregnancy (Cat.B). Nursing mothers.
Interaction(s):
Do not apply other products (makeup, sunscreen, lip balm, etc) to area during treatment.
Adverse Reaction(s):
Drying, flaking, burning/tingling sensation, erythema, pigmentation changes.
How Supplied:
Crm—2g, 5g
Medivir公司（STO計算：MVIRB）和Meda公司今天宣布了一項協議，以商業化Medivir公司的冷瘡產品將在北美銷售的商品名為 Xerese™。
根據協議條款，Meda公司授予的獨家代理權，市場，銷售和分銷 Xerese™在美國，加拿大和墨西哥的治療感冒瘡（唇皰疹）。除了資金的商業發展 Xerese™，梅達將支付500萬美元的前期和發射前的里程碑和兩位數的版稅銷售 Medivir公司的獨家報導權。
Xerese™ - 相結合的產物阿昔洛韋和氫化可的松 - 獲得 FDA的上市批准2009年7月。基於強勁的臨床數據，Xerese™被賦予了標籤，它的區別是從其他專題皰疹產品目前在市場上。
“我很高興地宣布這一夥伴關係，這是一個強大的驗證了產品，代表了第一步，為全球商業化的冷瘡的產品，”羅恩說龍，Medivir公司的首席執行官，並繼續說，“梅達的證明領導營銷製藥產品和了解美國市場動態，使其成為理想的合作夥伴 Xerese™。我們相信，梅達將使新產品是成功的，“羅恩龍結束。
“Xerese™是一個非常有趣的除了我們的產品組合在美國。這是已註冊並具有獨特的，與眾不同的索賠。當商業庫存在的地方，我們將啟動它。我們期待著與 Medivir公司的合作，而且我們能夠共同地開發新的適應症 Xerese™“說，安德斯Lönner首席執行官梅達。
關於 Xerese™
Xerese™（Xerclear™在歐洲） - 專利組合的5％和1％的氫化可的松阿昔洛韋在Medivir公司專有的精華配方 - 是一個熱門的產品用於治療復發性唇皰疹。指示文本通過美國 FDA批准，國家“Xerese™的適應症為早期治療復發性唇皰疹（唇皰疹），以減少潰瘍性皰疹的可能性，縮短癒合時間病變在成人和adolecents（12歲以上）“。 Xerese™是第一個熱門產品，在對照臨床試驗中已經顯示出顯著（P“0.0001與安慰劑相比）減少潰瘍性病變的發展過程中一個寒冷的疼痛發作。
關於唇皰疹
復發性唇皰疹（唇皰疹）是一種常見的感染，影響了三分之一的人口在西方世界造成約六億發作，每年有57億人擁有三個或更多的事件每年。絕大多數案件是由單純皰疹病毒1型（HSV - 1）。與大多數病毒，皰疹病毒還沒有完全消除人體的免疫反應。相反，它建立了一個慢性的，潛在的和終身感染感覺神經節。在以後的日子，病毒可能會被重新激活和旅行回皮膚 - 經常在嘴和鼻子 - 臨床事件引發唇皰疹的復發。該病毒被重新激活的因素如陽光和壓力。
今天，只有1-2％的事件的處理。產品立足抗病毒物質，如阿昔洛韋，噴昔洛韋，泛昔洛韋和萬乃洛韋是最常用的治療方案。市場外用治療皰疹感染在美國和歐洲的2.3億美元，預計美元和1.7億美元，分別。
