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Podofilox Topical Solution

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Podofilox Topical Solution

CLINICAL PHARMACOLOGY

Mechanism of Action

Treatment of genital warts with podofilox (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 0.05 mL of 0.5% podofilox (podofilox) solution to external genitalia did not result in detectable serum levels.Applications of 0.1 to 1.5 mL 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 clinical studies with podofilox (podofilox) solution,the test product and its vehicle were applied in a double-blind fashion to comparable patient groups.Patients were treated for two to four weeks, and reevaluated at a two-week follow-up examination. Although the number of patients and warts evaluated at each time period varied,the results among investigators were relatively consistent.

The following table represents the responses noted in terms of frequency of response by lesions treated and the overall response by patients. Data are presented for the 2-week follow-up only for those patients evaluated at that time point.

Responses in Treated Patients
 

Initially

Cleared*

Recurred after

Clearing*

Cleared

at 2-Week Follow-up*

%Warts
(n=524)
79%
(412/524)
35%
(146/412)
60%
(269/449)
% Patients
(n=70)
50%
(35/70)
60%
(21/35)
25%
(14/57)

*Cleared and clearing mean no visible wart tissue remained at the treated sites

Last reviewed on RxList: 6/14/2005
This monograph has been modified to include the generic and brand name in many instances.

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