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| |  Aldara Cream First New Alternative to Surgery for Genital Warts ST. PAUL, Minn., March 3, 1997 - The U.S. Food and Drug Administration (FDA) has cleared Aldara(TM) (imiquimod) cream for marketing in the treatment of external genital and perianal warts. Aldara cream was discovered by 3M Pharmaceuticals, a division of 3M Company. It is the newest in a class of drugs called immune response modifiers and represents the first new therapeutic approach to genital warts in five years. It provides a safe and effective new treatment for an estimated 4 million Americans with have genital warts. Genital warts is a sexually transmitted disease (STD) caused by the human papilloma virus (HPV). HPV is one of the most common -- and least talked about -- of all STDs; at least 1O to 20 % of sexually active Americans are thought to be infected. Genital warts is growing at a rate of 750,000 new cases each year, is spread by sexual contact with an infected partner and is highly contagious. This life long virus can cause warts in the genital and perianal areas in women and men. Male sexual partners of infected women often have HPV penile infection. Genital warts may cause itching, burning, pain and tenderness. Although there is no cure for genital warts, treatment can alleviate physical symptoms and psychological reactions such as problems with sexuality, shame, embarrassment and self-blame. Aldara is a vanishing cream that is applied by the patient and will be available by prescription only. It is indicated for treatment of external genital and perianal warts in adults. "Many patients have previously avoided treatment for genital warts because of fear of chemical and surgical procedures," notes Karl Beutner, MD, PhD, Associate Clinical Professor, University of California, San Francisco and chief investigator in the clinical trial of Aldara. "Self-administered Aldara cream is an effective, patient-friendly treatment that can be applied in the privacy of home to clear up warts." In a clinical trial with 209 patients, 50% (72% women, 33% men) had wart clearance with Aldara cream after 16 weeks of therapy compared to 11% of vehicle group. Of those who cleared, 72% (n=39/54) of patients from the Aldara group and 82% (n=9/11) of the vehicle group remained wart clear after 12 weeks of follow-up. Aldara cream was generally well-tolerated. Most patients experienced a variety of local skin reactions; most experienced redness (61%) and some experienced erosion (30%) and flaking (20%), but these tended to be mild to moderate in intensity. Only 4% of clinical trial patients reported pain and less than 2% is continued the treatment due to skin reactions. "Until recently, most treatment options were tissue destructive, which can be painful," says Dr. Beutner. Prior to Aldara, other available treatments for genital warts included removing them by chemical agents that create a chemical burn, procedures such as a loop electrocautery excision (burning), surgery to remove the wart, laser excision, cryotherapy (freezing), interferon injections, and tissue destructive drugs such as podofilox and podophyllin. "Aldara cream represents a new option in the management of this common problem," says Dr. Beutner.
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