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Condylox Topical

Genital warts (HPV) facts

  • Genital warts are caused by infection with a subgroup of the human papillomaviruses (HPVs).
  • Another subgroup of the HPVs that infect the anogenital tract can lead to precancerous changes in the uterine cervix and cause cervical cancer.
  • HPV infection is now considered to be the most common sexually-transmitted infection (sexually transmitted disease, STD) in the U.S., and it is believed that at least 75% of the reproductive-age population has been infected with sexually-transmitted HPV at some point in life.
  • HPV infection is common and does not usually lead to the development of warts, cancers, or even symptoms.
  • HPV infection of the genital tract is transmitted through sexual contact, although non-sexual transmission is also possible.
  • In many cases genital warts do not cause any symptoms, but they are sometimes associated with itching, burning, or tenderness.
  • ...

Condylox Topical

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CLINICAL PHARMACOLOGY

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.

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