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

FLORHAM PARK, N.J., Jan. 5, 2011 /PRNewswire/ -- PharmaDerm, a division of Nycomed US Inc., announced today that VEREGEN® (sinecatechins) Ointment, 15%, a topical medication for the treatment of external genital and perianal warts (EGWs), has been added as a new therapeutic option in the 2010 Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases (STD) Treatment Guidelines.(1) The new report, developed by the CDC after consultation with a group of professionals knowledgeable in the field of STDs, was published recently in the December 17 issue of Morbidity and Mortality Weekly Report.

VEREGEN® is now listed as a patient-applied option as part of the "Recommended Regimens for External Genital Warts" section of the guidelines. Consistent with the product label, the updated guidelines provide recommendations for the use of VEREGEN® in immunocompetent patients ages 18 years and older and instructs patients to apply the ointment three times daily until complete clearance of warts, but no longer than 16 weeks.

EGWs, which appear on the outside of the genitals or around the outside of the anus (perianal warts), are the most common STD in the U.S.(2) Caused by the human papillomavirus (HPV), if left untreated, EGWs can grow larger, interfering with bowel movements, urination and sexual intercourse.(3) Approximately 20 million Americans are currently infected with HPV and another 6.2 million people become newly infected each year.(4)

"The CDC STD Treatment Guidelines provide an important source of clinical guidance on both the prevention and management of HPV in the U.S.," stated Theodore Rosen, MD, Professor of Dermatology at Baylor College of Medicine. "Based on the latest scientific evidence, the updated guidelines provide clear direction on how VEREGEN® can routinely be incorporated into medical practice as a safe and effective option for patients seeking treatment for external genital warts."

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.

VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds. Do not expose skin that has been treated with VEREGEN® to the sun or ultraviolet light because VEREGEN® has not been tested in these conditions. Safety and efficacy of VEREGEN® have not been established in immunosuppressed or pediatric patients, or pregnant women, or for the treatment of external genital and perianal warts beyond 16 weeks or for multiple treatment courses.

The most common adverse reactions that occurred in more than 20% of patients in studies with VEREGEN® were reactions of the skin and application site. These included reddening of the skin, itching, burning, pain or discomfort, skin ulcers, wearing down of the skin, swelling, hard spots, and rash with blisters.

For more information about VEREGEN®, please refer to the full Prescribing Information and associated medication guide at http://www.veregen.com

About Nycomed USNycomed US Inc. is a subsidiary of Nycomed and operates two divisions in the United States focused on specialty pharmaceuticals in dermatology.  Founded in 1849, Fougera is a division of Nycomed US Inc. and is the leading manufacturer and distributor of a wide range of topical products.  The PharmaDerm division is dedicated to developing and commercializing novel prescription products to treat diseases and conditions of the skin – the largest organ of the human body.  For more information on Fougera's complete line of products, please call Fougera Customer Service at (800) 645-9833 or visit the company online at www.fougera.com.  Information on PharmaDerm products can be found online at www.pharmaderm.com.  More information is also available at www.nycomedus.com.(1) Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2010. MMWR 2010;59(No. RR-12):70-74.(2) Rubano E, Shah BR. Genital warts. eMedicine. http://emedicine.medscape.com/article/763014-overview. Updated Aug 16, 2010. Accessed October 15, 2010.(3) Genital warts. American Academy of Dermatology website. http://aad.org/public/publications/pamphlets/viral_genital.html. Accessed December 30, 2010.(4) CDC Fact Sheet – Genital HPV. CDC website. http://www.edcp.org/pdf/hpv_fact_sheet.pdf. Accessed October 15, 2010.(5) Bradley Pharmaceuticals, Inc. (2007, December 14). Bradley Pharmaceuticals Launches Veregen™ (sinecatechins) Ointment, 15% [Press release]. http://www.prnewswire.com/news-releases/bradley-pharmaceuticals-launches-veregentm-sinecatechins-ointment-15-58729832.html. Accessed October 15, 2010.(6) Meltzer SM, Monk BJ, Tewari KS. Green tea catechins for treatment of external genital warts. Am J Obstet Gynecol. 2009;200:233.e1-233.e7.(7) Cabrera C, Artacho R, Gimenez R. Beneficial effects of green tea—a review. J Am Coll Nutr. 2006;25(2):79-99.(8) Veregen Ointment, 15% [package insert]. Melville, NY: PharmaDerm, a division of Nycomed US, Inc.; 2008.
'/>"/>

SOURCE PharmaDerm
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CHMP Recommends Expanded Use of Angiox(R) (Bivalirudin) in Europe for Patients With Acute Coronary Syndromes
2. Independent Data Safety Monitoring Board Recommends Continuation of Sangarts Pivotal Phase III Trials of Hemospan(R) Following Second Interim Review
3. FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
4. FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
5. Task Force Recommends Screening for Hearing Loss in All Newborns
6. CHMP Recommends Approval of New Indication for Enbrel(R) as Treatment for Severe Psoriasis in Paediatric Patients
7. Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout
8. CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors
9. Independent Data Monitoring Committee Recommends Resuming Enrollment of Non-Squamous NSCLC Patients in the Motesanib MONET1 Trial
10. Task Force Recommends Using Aspirin to Prevent Cardiovascular Disease When the Benefits Outweigh the Harms
11. FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... -- In a startling report released today, National Safety Council ... comprehensive, proven plan to eliminate prescription opioid overdoses. Prescription ... are tackling the worst drug crisis in recorded U.S. history, assigned ... Kentucky , New Mexico , ... 28 failing states, three – Michigan , ...
(Date:6/23/2016)... June 23, 2016 Capricor ... ), a biotechnology company focused on the discovery, ... that patient enrollment in its ongoing randomized HOPE-Duchenne ... exceeded 50% of its 24-patient target. Capricor expects ... third quarter of 2016, and to report top ...
(Date:6/23/2016)... , June 23, 2016 , ... Thursday, July 7, 2016 , , , , LOCATION: , ... , , , , EXPERT PANELISTS:  , , , Frost ... Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh ... The global pharmaceutical industry is witnessing an exceptional era. Several ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors ... Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green ... hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... June ... about the dangers associated with chronic pain and the benefits of holistic treatments, ... individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is ...
(Date:6/24/2016)... ... , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys ... peers for this recognition are considered among the top 2 percent of lawyers practicing ... members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. ...
(Date:6/24/2016)... ... ... of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum Wage’ ... 2020 and then adjusting it yearly to increase at the same rate as the median ... floor does not erode again, and make future increases more predictable. , The company is ...
Breaking Medicine News(10 mins):