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The Next Viagra?

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

Tantalizing Possibilities, Alarming Problems continued...

Doe liked Uprima so much that in April he testified in favor of the drug's approval before an FDA advisory committee; his expenses to come to Washington were paid for by drugmaker TAP.

Robert Carelli, a 69-year-old retired teacher from Thousand Oaks, Calif., also participated in a Uprima trial for the better part of a year. He, too, was pleased with how the drug helped him sexually -- at first.

"I was happy with it for a while," says Carelli, who also received an honorarium from TAP to speak on behalf of Uprima. "It worked; it certainly corrected the problem." But the drug also made him nauseated -- mildly so about 10% of the time and extremely so on a couple of occasions.

"That hardly made me feel amorous," Carelli says. Eventually, the nausea bothered him so much that he gave up on the drug and switched to Viagra.

Some men who took Uprima in clinical trials suffered more serious side effects. According to FDA medical reviewers, one in 30 men who took Uprima in its optimal 4 milligram dose either fainted or experienced dangerously low blood pressure. One 33-year-old man blacked out while driving about 30 minutes after taking a 4-milligram dose and crashed into a fence. Another man, 56, had his blood pressure plunge, lost consciousness for 15 minutes, then woke up and vomited before fainting again in the emergency room. Other patients fainted and struck their heads, suffering lacerations and fractures.

Most of the reported problems took place in doctors' offices where treatment was readily available.

Serious side effects were much more common with men who took 4 milligrams or more of the drug, as opposed to 2 milligrams. But the effectiveness of the lower dose was so limited, FDA medical reviewer Mark Hirsch, MD, told an agency advisory committee in April, that "few patients will actually remain on the dose of 2 milligrams when offered the opportunity to take higher doses."

Despite the questions raised about Uprima, the advisory committee voted 9 to 3 to recommend that the agency approve the drug. Now, with TAP withdrawing its application, the FDA will not be considering the drug's fate until the manufacturer resubmits its request, something the company vows to do after completing two ongoing clinical trials.

"We are still very confident," TAP spokesperson Kim Modroy told WebMD. "We hope by taking this extra time we will have a much stronger product."

Same Ends, Different Means

If Uprima does get approved, it will face comparison with its world-famous predecessor. Viagra and Uprima both facilitate erections, but in different ways. Viagra effects a more direct response in the vascular system, temporarily widening arteries and allowing more blood flow to the penis. Uprima works by inhibiting a part of the brain that controls the body's smooth muscle contractions. Curbing those contractions allows more blood to flow, ideally with the same happy results.

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