口腔疱疹药物Sitavig获得FDA批准

圣路易斯(MD Consult)——2013年4月15日，BioAlliance制药公司宣布，美国食品药品管理局(FDA)已批准Sitavig(阿昔洛韦)用于治疗复发性口唇疱疹。Sitavig是一种黏膜附着性片剂，由患者将其置于牙龈上，从而直接向嘴唇感染部位释放出高浓度的阿昔洛韦。

在一项纳入775例患者的3期国际性研究中，只需使用1片含有50 mg阿昔洛韦的Sitavig，即可在愈合时间方面显示出很强疗效。BioAlliance评论指出，这种药物还表现出极佳的耐受性。

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ST LOUIS (MD Consult) - On April 15, 2013, BioAlliance Pharma announced that the US Food and Drug Administration (FDA) has approved Sitavig (acyclovir) for the the treatment of recurrent herpes labialis. Sitavig is formulated as a mucoadhesive tablet that a patient places on the gum, which results in the delivery of a high concentration of acyclovir directly to the lip at the site of infection.

In a phase 3 international study of 775 patients, Sitavig demonstrated a high level of efficacy in terms of healing time with the use of only 1 tablet containing 50 mg of acyclovir. BioAlliance remarked that the drug also exhibited an excellent tolerance profile.