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| |  Safety and Efficacy Data Presented on Pfizer Oral Drug for Impotence NEW YORK, May 6, 1996-- According to data presented today at the American Urological Association annual meeting, a new oral medicine helped the majority of men with male erectile dysfunction (MED), or impotence, in three clinical trials. Impotence affects an estimated 140 million men worldwide, although it is believed that this condition is vastly underreported. Over half of all impotence cases are believed to have physical causes such as diabetes, or circulatory, neurological, or urological conditions. Current impotence therapies include implants and injections. International experts including Pfizer scientists at the AUA meeting reported data on Viagra, (sildenafil), Pfizer's novel oral drug in late-stage development, from three double-blind, randomized, controlled studies involving men with MED of no known cause. Among the highlights of their findings are: -- The drug was well tolerated in a four-week dose-controlled trial of 351 men. Of the patients who received Viagra in this study, 65 percent, 79 percent, and 88 percent reported improved erections on respective doses of 10mg, 25mg, and 50mg, compared with 39 percent of the patients who received the placebo. -- In a 28-day study of 43 patients, Viagra improved the quality of erections of 92 percent of patients taking the drug. When the same patients received a placebo, only 27 percent responded; -- In another study, ten out of 12 MED patients given Viagra over the course of 7 days reported an improvement in erections. When the same patients took placebo, two of twelve responded. The researchers additionally presented data on Viagra's mechanism of action. The drug enhances the natural response to sexual stimulation by blocking the effect of an enzyme, phosphodiesterase-5, effectively increasing blood flow to the penis. Blood flow to the penis is necessary for an erection. "Impotence has a major, and sometimes devastating, psychological and social impact on patients and their partners," said George M. Milne, president of Pfizer Central Research. "Effective drugs currently available involve injections and for that reason have not been widely accepted. Viagra, because it is a pill and enhances the normal sexual response, offers advantages to these patients in terms of both convenience and safety." "This is one of the most exciting new developments in the clinical research for erectile dysfunction," said Tom F. Lue, M.D., Professor or Urology at The University of California, San Francisco. "If further clinical trials prove its efficacy and safety, it may be a dream come true for many patients who are looking for a magic pill to improve their erection." Pfizer Inc. (NYSE: PFE) is a research-based, diversified health-care company with global operations. The company reported sales of more than $10 billion in 1995, and expects to spend about $1.7 billion on research and development in 1996.
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