Inconclusive results from Viagra studies in women do not support regulatory filing

Inconclusive results from Viagra studies in women do not support regulatory filing

NEW YORK, February 27, 2004 -- Pfizer said that results from clinical studies investigating the use of Viagra (sildenafil citrate) as a treatment for female sexual arousal disorder (FSAD) do not support a regulatory filing. Pfizer began its FSAD research program in 1996. To date the company has conducted several large-scale placebo-controlled studies involving approximately 3,000 women. While Viagra was found to be safe in all studies, efficacy data were inconclusive. Pfizer said the program would draw to a close this month.

A highly prevalent condition with a major impact on quality of life, FSAD is a complex constellation of symptoms that are difficult to identify, measure and treat. The American Foundation for Urological Diseases defines FSAD as a persistent inability to attain or maintain sufficient sexual excitement that causes personal distress. The condition, which may occur alone or in conjunction with other female sexual disorders, is believed to result from a broad range of medical and psychological conditions.

"FSAD is an emerging area of research and is far more complex than male erectile dysfunction," said Dr. Joe Feczko, president of Worldwide Development at Pfizer. "Diagnosing FSAD involves assessing physical, emotional and relationship factors, and these complex and interdependent factors make measuring a medicine's effect very difficult."

Pfizer discovered and over the next decade developed Viagra, the world's leading oral treatment for male erectile dysfunction. Since Viagra's approval in 1998, more than 23 million men have been prescribed the medicine worldwide.

"While we are disappointed that the FSAD program was not more successful, this is the nature of drug development," said Karen Katen, president of Pfizer Global Pharmaceuticals, executive vice president, Pfizer Inc. "We make substantial financial investments, marshal the talents of our best scientists and clinicians, and spend years studying potential treatments only to find that they do not meet the requirements for regulatory approval".

Source: Pfizer www.pfizer.com

Posted: February 2004


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