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Home Genital Warts Genital Warts FDA Approves Zyclara to Treat Genital Warts

FDA Approves Zyclara to Treat Genital Warts

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Graceway pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has approved Zyclara® (imiquimod) 3.75% cream to treat genital and perianal warts in patients 12 years or age and older.

Zyclara® and another, older preparation of imiquimod, Aldara® 5% Cream, both are patient-applied topical agents that work by stimulating an immune response in the skin cells around the treated area. In Phase III trials Zyclara® used daily for up to eight weeks achieved total clearance of warts (including lesions present at enrollment as well as any that developed during the study) in 28.3% of those in the treatment group, compared with 9.4% of those who received a placebo. The cream worked better in females, with an efficacy of 37% compared to 19% in males.

The company touts Zyclara® as a “short acting” treatment: The cream can be applied daily for up to eight weeks, compared to Aldara’s® three-times weekly regimen used for up to 16-weeks.