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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...

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.

The way the two drugs get into the body differs, too. Viagra, a pill, is swallowed, while Uprima is a lozenge meant to be dissolved under the tongue. Uprima bypasses the stomach to enter the blood stream directly, so it works faster than Viagra. That would score a point for Uprima on spontaneity, since it could be taken right after a meal. Viagra is less effective, sometimes even useless, if taken on a full stomach -- a big disadvantage when an evening turns romantic after dessert.

Neither drug is an aphrodisiac: They can make it easier for a man to get an erection, but they can't improve his libido. And they won't make him desire a partner any more than he would on his own.

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