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CDC Recommends VEREGEN® as Therapeutic Option for External Genital Warts in the 2010 Sexually Transmitted Diseases Treatment Guidelines
Date:1/5/2011

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Approved by the U.S. Food and Drug Administration (FDA) in October 2006, VEREGEN® is the first prescription botanical drug approved for use in the U.S., and the first new prescription treatment for EGWs in more than a decade.(5) VEREGEN® is derived from green tea leaves from the plant Camellia sinensis (L.) O Kuntze, and contains a proprietary mixture of catechins and other green tea components. The health benefits associated with green tea catechins, which comprise 85 to 95 percent of the drug substance in VEREGEN®, are attributed in part to their antioxidative, immunostimulatory and antiviral properties.(6) However, the mode of action of VEREGEN® involved in the clearance of EGWs is unknown.  Future studies are necessary to fully understand the role of catechins in human health.(7)

VEREGEN® has demonstrated to be effective in clearing both existing and newly emerging EGWs, with complete clearance in 53.6 percent of all patients treated in two pivotal, randomized, double-blind, vehicle-controlled, Phase 3 studies. VEREGEN® also demonstrated low recurrence rates (6.8%) at 12 weeks post treatment during these trials.(8)

"EGWs can be distressing for patients," said Ralph N. Landau, Ph.D., Senior Vice President, Research and Development of Nycomed US Inc. "We are pleased that experts in the field of STDs acknowledge VEREGEN® as a proven intervention for EGWs that meets the goals of treatment – complete clearance in both existing and newly emerging warts, with a low rate of recurrence."

Important Product Safety Information About VEREGEN®VEREGEN® Ointment, 15% is a medicine for skin use only (topical) for the treatment of warts on the outside of the genitals and around the outside of the anus. It is not a treatment for warts in the vagina, cervix, or inside the anus. Your doctor may recommend examination and screening tests (such as a Pap smear) to evaluate these areas.


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