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Veregen

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Veregen

CLINICAL PHARMACOLOGY

Mechanism of Action

The mode of action of Veregen® involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding is unknown.

Pharmacodynamics

The pharmacodynamics of Veregen® is unknown.

Pharmacokinetics

Systemic exposure to EGCg, EGC, ECg, and EC were evaluated following either topical application of Veregen® to subjects with external genital and perianal warts (250 mg applied 3 times a day for 7 days) or following oral ingestion of green tea beverage (500 mL ingested 3 times a day for 7 days). Following topical application of Veregen®, plasma concentration of all 4 catechins were below the limit of quantification ( < 5 ng/mL) on Day 1. After application of Veregen® for 7 days, plasma EGC, ECg, and EC concentrations were below the limit of quantification while plasma concentration of EGCg were measurable in 2 out of 20 subjects. The mean maximal plasma concentration (Cmax) of EGCg was 10.1 ng/mL and the mean area under the concentration versus time curve (AUC) of EGCg was 52.2 ng•h/mL in these 2 subjects. Oral ingestion of green tea beverage resulted in measurable concentration of EGCg in all subjects on both Day 1 and Day 7, with mean (SD) Cmax of 23.0 (12.0) ng/mL and AUC of 104.6 (39.0) ng•h/mL on Day 7.

Clinical Studies

Two randomized, double-blind, vehicle-controlled trials were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent subjects 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).

Over both trials the median baseline wart area was 51 mm² (range 12 to 585 mm² ), and the median baseline number of warts was 6 (range 2 to 30).

The primary efficacy outcome measure was the response rate defined as the proportion of subjects with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 2 and 3 for all randomized subjects dispensed medication.

Table 2: Efficacy by Region

  Complete Clearance
All Countries (includes the United States)
  Veregen® 15% (N = 397) 213 (53.6%)
  Vehicle (N = 207) 73 (35.3%)
United States
  Veregen® 15% (N = 21) 5 (23.8%)
  Vehicle (N = 9) 0 (0.0%)

Table 3: Efficacy by Gender

  Complete Clearance
Males
  Veregen® 15% (N = 205) 97 (47.3%)
  Vehicle (N = 118) 34 (28.8%)
Females
  Veregen® 15% (N = 192) 116 (60.4%)
  Vehicle (N = 89) 39 (43.8%)

Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.

The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.

Last reviewed on RxList: 12/7/2012
This monograph has been modified to include the generic and brand name in many instances.

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