Mechanism of Action

Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue.The exact mechanism of action is unknown.

Pharmacokinetics

In systemic absorption studies in 52 patients, topical application of 0.05mL of an ethanolic solution containing 0.5% podofilox to external genitalia did not result in detectable serum levels. Applications of 0.1 to 1.5mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application. The elimination half-life ranged from 1.0 to 4.5 hours. The drug was not found to accumulate after multiple treatments.

CLINICAL STUDIES

In the first multicenter clinical study in 326 patients with anogenital warts, Condylox® Gel 0.5% and its vehicle were applied in a double-blind fashion to comparable patient groups. Of the 260 patients with efficacy data, 176 were treated with Condylox® Gel 0.5%. Patients applied Condylox® Gel 0.5% twice daily for three consecutive days followed by a 4 day †rest† period.

At the end of 4 weeks, 38.4% of the patients had complete clearing of the wart tissue when treated with Condylox® Gel 0.5%.

In the second multicenter clinical trial in 108 evaluable patients with anogenital warts, Condylox® (podofilox) Topical Solution 0.5% was compared with Condylox® Gel 0.5% for efficacy. As in the first clinical trial, patients applied Condylox® Gel 0.5% twice daily for three consecutive days followed by a four day "rest" period.

Similar clearance rates were observed. At the end of 4 weeks, 25.6% of the patients had complete clearing of the wart tissue when treated with Condylox® Gel 0.5%.

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