FDA Approves Alternative to Viagra

Nod for Levitra ends impotence pill monopoly

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By
HealthDay Reporter

(HealthDay is the new name for HealthScout News.)

WEDNESDAY, Aug. 20, 2003 (HealthDayNews) -- Make room, Viagra. You're not the only erection pill on the block anymore.

The Food and Drug Administration on Tuesday approved Levitra, the second impotence drug to be marketed in the United States and the first to rival Viagra, which has singlehandedly dominated the U.S. scene since 1998.

The drug, which has been available in Europe since March, is expected to hit U.S. pharmacy shelves within a few weeks. A third drug for erectile dysfunction (ED), Cialis, has also been approved in Europe and is expected to debut this side of the Atlantic later this year. Still another, Uprima, applied for approval last year after having withdrawn because it led to fainting.

"It's exciting news, very exciting," says Dr. Natan Bar-Chama, director of male reproductive medicine and surgery at Mount Sinai Medical Center in New York City.

Some 30 million men in the United States suffer from ED, and it is estimated that more than half of all men over the age of 40 are affected by the disorder to some degree. Only about 10 percent or 15 percent of men with the problem are being treated, however.

"Despite the media attention, there is still a huge underlying need to have men realize that they may have a problem and to raise their hand and come to their doctor," says Dr. Marc Gittelman, founder and director of the Miami Center for Sexual Health, who has also been involved in clinical trials for Viagra, Levitra, and Cialis.

It's not entirely clear how Levitra, made by Bayer AG and distributed in the United States by GlaxoSmithKline, and Viagra, made by Pfizer, will complement or compete with each other. Both drugs belong to the same family of medications: PDE5, or phosphodiesterase 5 inhibitors. These both work by inhibiting the enzyme that degrades the erection, Gittelman explains.

Experts anticipate that Levitra (scientifically known as vardenafil) will be a natural for men who have not benefited from Viagra. "Certainly patients who have tried Viagra and have had suboptimal response now have a new agent and are candidates," Bar-Chama says.

"Virgin" patients will also be candidates. "Millions of men who are untreated we are hoping will come in," Gittelman says. "Levitra will be used as a first-line drug. It's an equal choice."

There have been no head-to-head comparisons of Levitra and Viagra, but much data is suggestive, Gittelman says. Levitra seems to work faster than Viagra, with a "window of opportunity" of 16 minutes to five hours vs. the average one to four hours that are indicated on Viagra's package insert.

There are also no food or alcohol restrictions on Levitra, so romantic dinners are not out of the question. The general recommendation for Viagra is to take it after a low-fat meal or on an empty stomach because fatty foods inhibit absorption of the drug.

Levitra also seemed to have some advantages in quality-of-life areas. "Men were actually pleased with the firmness of their erection. There was an improvement of orgasm function [a category that includes ease of achieving an orgasm]. They also felt that their general overall sexual experience was improved," Gittelman says.

Finally, 86 percent to 92 percent of men are expected to have improvement in erections on Levitra. Of all the men that respond, 91 percent are expected to have success in subsequent attempts.

This data is based on more than 50 clinical trials involving more than 5,700 men.

The recommended dose for Levitra is 10 milligrams. A 20-mg pill is also available for those who don't respond, along with 2.5 mg and 5 mg for patients who have certain medical conditions or are taking other drugs. Levitra should not be used more than once a day.

The medication also comes with certain warnings. It should not be used by people taking nitrate-containing medications or alpha-blockers, or who have a rare heart condition known as "prolongation of the QT interval."

It's also not recommended for those who have had a heart attack or stroke within the last six months, who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment, end stage renal failure requiring dialysis, or retinitis pigmentosa. The most common side effects reported were headaches, flushing, rhinitis and indigestion.

In the meantime, Pfizer has filed a lawsuit claiming that one of its patents would be infringed by the sale of Levitra.

More information

For more on the new drug, visit Levitra.com. For more on sexual function issues, visit the Consortium for Improvement in Erectile Function or the National Institute of Diabetes and Digestive and Kidney Diseases.

SOURCES: Natan Bar-Chama, M.D., director of male reproductive medicine and surgery, Mount Sinai Medical Center, New York; Marc Gittelman, M.D., founder and director, Miami Center for Sexual Health and voluntary associate professor, University of Miami School of Medicine; U.S. Food and Drug Administration news release

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