Posted on: Saturday, September 13, 2003
Viagra alternatives beginning to hit market
By Jane Allen
Los Angeles Times
The little blue pill that revolutionized impotence treatment now has some competition.
Levitra, approved last month by the Food and Drug Administration, is the first in a growing array of Viagra alternatives and can work in about the same amount of time as Viagra — generally within 30 to 60 minutes.
"Everybody who tried Viagra and wasn't happy with it is going to try this," said Dr. Stephen Auerbach, a urologist in Newport Beach, Calif., who specializes in male sexual dysfunction.
Another pill, whose effects last 36 hours, could be approved by year's end. A nasal spray, a topical cream and a pill that dissolves under the tongue also are in the pipeline and could be available in two to three years.
These noninvasive approaches have developed relatively quickly during the past few years. Not long ago, men were often too embarrassed to seek treatment for erectile dysfunction and, even when they did, their only options were injections, vacuum pumps and implants.
Viagra changed that. Men had a treatment that was easy, painless and discreet — one that only took effect when they were aroused, making sex more spontaneous.
The massive marketing campaign brought impotence out of the shadows.
Men became more willing to discuss the problem with their doctors and try the pill. And try it they did. Pfizer Inc. sells $1.7 billion worth of Viagra each year worldwide; $1 billion of it in the United States.
"For a guy, our whole self-image is brought up around our erections," Auerbach said. "We may not be the studs we used to be, but in our brain we are."
Impotence has many causes, such as vascular problems from high blood pressure, diabetes and cardiovascular disease; neurological problems stemming from surgery, spinal injuries or diseases; psychological problems such as depression and anxiety; and medication side effects.
Although Viagra can work no matter what the cause, it doesn't help all men. Its effectiveness is about 70 percent overall and it works best for men with mild to moderate impotence.
Some men for whom it might work don't give the drug a second chance after a disappointing experience. Some are put off by having to take it on an empty stomach.
Levitra and its followers aim to pick up where Viagra left off.
Manufactured by Bayer and marketed by GlaxoSmithKline, Levitra was approved by the FDA on Aug. 19. It belongs to the same class of medication as Viagra (sildenafil), and both work for several hours. A third drug in that same class, Cialis (tadalafil), promises the longest-lasting effects: up to 36 hours, offering the most spontaneity of any treatment. Eli Lilly & Co. and Icos Corp., which already sell Cialis in Europe, are hoping for FDA go-ahead by year's end.
All three pills improve blood flow to the penis by blocking an enzyme called phosphodiesterase 5 or PDE5. But the speed at which they take effect and how long the effects last varies. With any of them, Auerbach said, "some people react very quickly, some react in an hour."
Although the impotence pills could work for most men with erection problems, they're not for everyone. Levitra, Viagra and Cialis shouldn't be used by men who take nitrate-containing heart medications, such as nitroglycerin, or alpha blockers for high blood pressure and enlarged prostates, such as Hytrin, Cardura or Flomax, because the combinations can make blood pressure plunge and cause fainting. Auerbach said patients on alpha blockers might be able to use Viagra if they wait four hours between medications.
Of the 30 million American men estimated to have at least occasional problems getting and sustaining an erection, only about 10 percent seek treatment. But the publicity that Viagra and Levitra have garnered — and that expected for the future options — may encourage more men to acknowledge the problem and be treated, rather than give up on reviving their sex life.
Just as former Senate Majority Leader Bob Dole, R-Kan., and baseball player Rafael Palmeiro spoke out about erectile dysfunction and in the process helped make Pfizer's diamond-shaped Viagra pill nearly as well-known as aspirin and heartburn drugs, the makers of Levitra hope that former NFL coach Mike Ditka can appeal to regular guys and further destigmatize the problem.
Viagra also has shifted impotence treatment from urologists to family practitioners and internists, who probably will be the biggest prescribers of the newer therapies, said Dr. Jacob Rajfer, a urologist at UCLA whose research into the biochemistry of erections led to the development of Viagra. Levitra's side effects, like those of Viagra, include headaches and flushing. It also may cause nasal congestion, while Viagra can cause indigestion and visual disturbances.
Meanwhile, several other noninvasive treatments that have been in major clinical trials may be more attractive to the 90 percent of men who aren't being treated:
• A drop of prostaglandin cream applied directly to the opening of the penis dilates local blood vessels in just five to 15 minutes. The cream contains alprostadil, used for years in penile injections. NexMed Inc. of Robbinsville, N.J., plans to seek FDA approval in late 2004. The drug has no major side effects, other than initial burning, stinging or tingling that bothered about 3 percent of the men who tested it; unlike Viagra, Levitra and Cialis, it doesn't interact with nitrates and alpha blockers.
• A nasal spray, called PT141, made by Palatin Technologies Inc. in Cranbury, N.J., works through the brain, stimulating sexual arousal. A sniff of the spray is taken about 30 minutes before sexual activity.
• A pill containing apomorphine hydrochloride, from TAP Pharmaceutical Products Inc., available in many countries as Uprima, awaits FDA approval. The pill dissolves under the tongue, bypassing the digestive system, blocking the release of the adrenaline that gets in the way of sexual arousal.
