Mechanism of Action
Treatment of genital 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 0.05
mL of 0.5% 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 Condylox (podofilox topical solution ) 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: 12/1/2008
This monograph has been modified to include the generic and brand name in many instances.