ST LOUIS (MD Consult) - On November 23, 2010, Eli Lilly announced that the US Food and Drug Administration (FDA) has approved Axiron (testosterone) topical solution CIII for replacement therapy in men with certain conditions associated with a deficiency or absence of testosterone. These conditions include primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The data submission package for Axiron included findings from a phase 3, multicenter, open-label, 120-day clinical study. Results showed that 84% of men who completed the study achieved average serum testosterone concentrations within the normal range of 300 to 1050 ng/dL. Additionally, after 120 days of treatment, 75% of responding patients finished the study on the recommended starting dose of 60 mg.

The most common adverse reactions reported in the study were skin application-site reactions, increased red blood cell counts, headaches, diarrhea, vomiting, and increased prostate-specific antigen levels.

Axiron is an alcohol-based solution applied to the underarm once daily using a metered-dose applicator. The recommended starting dose is 60 mg applied once daily, preferably at the same time each morning. Patients who use antiperspirant or deodorant should apply it before using Axiron to avoid contamination of the deodorant. After the application area is dry, it should remain covered with clothing and the area should be washed well after clothing is removed.

Patients should be warned that Axiron can be transferred to others if contact is made with the area where Axiron was applied. Signs of puberty that are not expected have occurred in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using topical testosterone products. Women and children should avoid contact with the unwashed or unclothed area where Axiron has been applied. If a woman or child makes contact with the application area, the contact area should immediately be washed with soap and water.

Because Axiron contains testosterone, it is considered a controlled substance under US law.

圣路易斯(MD Consult)——2010年11月23日，美国礼来公司宣布，美国食品药品管理局(FDA)已批准Axiron(睾酮)局部外用涂液CIII用于患有某些睾酮缺乏相关疾病的男性，作为替代治疗药。这些疾病包括原发性性腺机能减退症(先天性或获得性)和低促性腺激素性性腺功能减退症(先天性或获得性)。

提交Axiron审批的数据包括一项历时120天、多中心、III期开放性临床研究的结果。结果显示，完成研究的男性中有84%血清睾酮浓度达到了正常范围，即300~1050 ng/dL。另外，在接受120天治疗后，有75%的起效患者以60 mg的推荐初始剂量完成该研究。

该研究中报告的最常见的不良反应是皮肤用药部位的反应、红细胞计数增加、头痛、腹泻、呕吐和前列腺特异性抗原水平升高。

Axiron是一种以乙醇为基础的溶液，腋下应用、每天1次，采用定量涂药器给药。推荐的初始剂量为60 mg、每天1次，最好在每日清晨的同一时间应用。若使用止汗剂或除臭剂，则应先于Axiron之前使用以避免除臭剂造成污染。在用药区干燥后应该用衣服将其遮盖，并在脱去衣服后充分清洗用药区。

应警告患者，其他人接触Axiron用药区后会产生间接用药。青少年意外与使用局部外用睾酮制剂的男性发生皮肤与皮肤接触而暴露于睾酮后，会出现不应有的青春期体征。女性和儿童应该避免接触未清洗或未用衣服遮盖的Axiron用药部位。若女性或儿童接触了用药部位，则应立即用肥皂和清水清洗接触部位。

由于Axiron含有睾酮，故在美国法律下被视为受管制药品。