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The Next Viagra?

Uprima was supposed to be the next hot drug for erectile dysfunction. What happened?
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WebMD Feature

July 10, 2000 -- In the two years since it rocketed onto the market -- and became, almost overnight, a household word -- the impotence drug Viagra has helped men with erection problems enjoy satisfying sex. The little blue pill fired the male imagination with the notion of an enduring and youthful virility that could last into the golden years.

But truth is, Viagra is not the sexual cure-all that many men who have problems with erectile dysfunction believed it to be. As many as two in five men who try the drug don't get the desired results. And at least 39 Viagra users have died, mostly men who were also taking other drugs, or who had serious heart disease (see the November-December 1998 issue of Clinical Therapeutics).

No wonder that early reports of another, perhaps better, drug were so tantalizing -- both to the media and to men who got no satisfaction from Viagra. The very name of the new drug -- Uprima -- conjured up images of supremacy and conquest.

Then, last week, came the news that threw a splash of cold water on these oh-so-fond hopes: TAP Pharmaceuticals, the maker of Uprima, unexpectedly -- perhaps temporarily -- withdrew its application for approval by the Food and Drug Administration (FDA).

Why did the company pull a product that just weeks ago had been widely expected to gain FDA approval and give Viagra a run for its money in the billion-dollar impotence market? Experts speculate that the agency may, in fact, have been poised to reject the drug's application or to severely restrict its recommended use. The reason: serious questions about the drug's safety at higher doses and its efficacy at lower ones.

Before submitting its application to the drug agency, TAP Pharmaceuticals tested Uprima on more than 2,700 men in final clinical trials. The experience of two of those men, interviewed by WebMD, offers a glimpse at the drug's possibilities -- and drawbacks.

Tantalizing Possibilities, Alarming Problems

When John Doe (not his real name) noticed his sexual functioning was waning, he went straight to his doctor for help. Doe knew about Viagra (the brand name for sildenafil). His doctor, of course, knew about it too, and promptly gave him a sample of the drug to try at home. But when the 59-year-old engineer from Cincinnati took the pill, something unexpected happened.

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