FDA approves second drug to treat erectile dysfunction

Wednesday, August 20th 2003, 12:00 am
By: News On 6

WASHINGTON (AP) _ The government has approved the sale of a second pill to treat erectile dysfunction, setting the stage for a fierce battle with Viagra in the billion-dollar-plus impotence market.

The new drug, Levitra, is in the same family as Viagra. Both work by targeting an enzyme important for maintaining an erection. The Food and Drug Administration approved Levitra Tuesday.

Until now, the blue, diamond-shaped Viagra pills have been the only oral prescription drug available for an estimated 30 million American men who suffer some degree of impotence _ most of whom don't seek medical therapy.

Levitra, made by Bayer AG and marketed by GlaxoSmithKline, recently began selling in Europe. A third impotence pill _ Cialis, from Eli Lilly & Co. and Icos Corp. _ also has European approval and is expected to hit U.S. pharmacies later this year.

All three drugs work in the same manner, and there have been no published studies directly comparing the pills to determine advantages of each.

The FDA approved Levitra, known chemically as vardenafil, based on studies showing that men were on average five times more likely to achieve an erection suitable for intercourse when taking the pill compared with those given a dummy medicine.

In studies of several thousand men, researchers reported that Viagra helped more than 70 percent improve their erections.

Like Viagra, Levitra comes with some serious warnings that dramatically limit the number of men eligible to take it.

The FDA said Levitra should never be used by men who:

_ Take nitrate-containing drugs for heart conditions.

_ Take medicines called alpha blockers, such as Cardura, for high blood pressure or enlarged prostate. The combination could cause plummeting blood pressure and fainting.

FDA also said Levitra is not for patients with a rare heart condition known as QT prolongation because the drug could cause an abnormal heart beat.

Nor is it for men who suffered a recent heart attack or stroke who have very low blood pressure or uncontrolled high blood pressure.

For otherwise healthy men, Levitra's main side effects were headache, flushing and a stuffy nose. About 2 percent became dizzy.

Men are advised to get a thorough physical exam before using Levitra for the first time, the FDA said.

The manufacturer said Levitra would be on pharmacy shelves within a few weeks but refused to release the price.

With the new competition, urologists expect a boom in direct-to-consumer advertising that might entice more men suffering from impotence to visit a doctor and check out their options.

Sales of Viagra, which hit the market in 1998, totaled $1.7 billion last year. Even before it had competition, Pfizer Inc. made the pill one of the nation's most heavily promoted drugs, spending $101 million on marketing in 2001 alone.

Bayer and Glaxo haven't detailed their marketing plans for Levitra yet, but they are beginning a three-year sponsorship deal with the National Football League reported to be worth about $18 million.