美国FDA批准Valeant制药公司的Luzu(luliconazole Cream) 用于治疗真菌感染引起的常见皮肤病

近日，Valeant制药北美公司获美国FDA批准的Luzu（ luliconazole Cream，卢立康唑霜1％）的新药，用于治疗18岁及以上足癣，红色毛癣菌和絮状表皮癣菌等癣菌引起的股癣患者。这些都是主要由皮肤真菌引起常见皮肤疾病。

LUZU®（卢立康唑）霜（1％），是为期一周，每日一次的治疗方案，适应症为股癣和皮肤癣，是目前唯一的治疗周期为一周的外用唑类抗真菌剂。所有其他经批准的治疗方案都需要进行为期两个星期的治疗。针对指状组合型脚癣需要每日一次为期两周的治疗。美国是北美首个批准的国家。卢立康唑已经于2005年已在在日本被批准上市。

批准日期：2012年11月15日 公司：Valeant制药

LUZU（卢立康唑 luliconazole）霜，1％用于局部使用

美国最初批准：2013年

最近的重大变化

适应症和用法：02/2018

作用机制

LUZU Cream，1％是唑类抗真菌药[见微生物学]。

适应症和用法

LUZU（卢立康唑）霜，1％是一种唑类抗真菌药，用于局部治疗由红色毛癣菌和絮状表皮癣菌引起的趾间足癣，股癣和体癣。

剂量和给药

•仅限局部使用。 不适用于眼科，口腔或阴道内使用。

•Interdigital Tinea Pedis：LUZU Cream，1％应每天一次施用于受影响的周围区域，持续2周。

•股癣和股癣：LUZU霜，1％应每天一次施用于受影响的皮肤和周围区域，持续1周。

剂量形式和强度

奶油，1％

禁忌症

没有。

不良反应

在临床试验中观察到的最常见的不良反应是应用部位反应，其发生在不到1％的受试者中。

如何提供/存储和处理

LUZU（卢立康唑）霜，1％是管中提供的白色乳膏，如下：

60克 NDC 99207-850-60

储存在20°至25°C（68°至77°F）; 允许偏差在15°至30°C（59°至86°F）之间[参见USP受控室温]。

完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a7016010-ce43-4c09-8d21-aeb697ffed31

Luzu (luliconazole) Cream 1%

General Information

Luzu (luliconazole) Cream 1% is an antifungal that belongs to the azole class. Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol. 

Luzu is specifically indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in adults 18 years of age and older.

Luzu is supplied as a cream for topical administration. The recommended dose is as follows: Interdigital Tinea Pedis: Luzu Cream, 1% should be applied to the affected and immediate surrounding area(s) once a day for two weeks. Tinea Cruris and Tinea Corporis: Luzu Cream, 1% should be applied to the affected skin and immediate surrounding area(s) once a day for one week. 

Clinical Results

FDA Approval

The FDA approval of Luzu was based on the following trials:

Interdigital Tinea Pedis:

The safety and efficacy of Luzu was eva luated in two randomized, double-blind, vehicle-controlled, multi-center clinical trials in 423 subjects with a clinical and culture-confirmed diagnosis of interdigital tinea pedis. Subjects were randomized to receive Luzu Cream, 1% or placebo, which was applied to the entire area of the forefeet including all interdigital web spaces and approximately 2.5 cm (1 in) of the surrounding area of the foot once daily for 14 days. Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 4 weeks post-treatment. Luzu Cream, 1% demonstrated complete clearance in subjects with interdigital tinea pedis. Study 1: 26% versus 2% and Study 2: 14% versus 3% for the Luzu versus placebo arms, respectively.

Tinea Cruris

A randomized, double-blind, vehicle-controlled, multi-center clinical trial in 256 subjects with a clinical and culture confirmed diagnosis of tinea cruris. Subjects were randomized to receive LUZU Cream, 1% or vehicle. Subjects applied either Luzu Cream 1% or vehicle cream to the affected area and approximately 2.5 cm (1 in) of the surrounding area once daily for 7 days. Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 3 weeks post-treatment. Luzu Cream, 1% demonstrated complete clearance in subjects with tinea cruris: 21% versus 4% for placebo.

Side Effects

Adverse effects associated with the use of Luzu may include, bu are not limited to, the following:

•application site reactions

Mechanism of Action

Luzu (luliconazole) Cream 1% is an antifungal that belongs to the azole class. Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol.