MONDAY, April 10 (HealthSCOUT) -- Men with impotence could soon have another drug option to help them achieve erections. An expert panel for the U.S. Food and Drug Administration unanimously recommended today that the agency approve apomorphine, or Uprima. If the agency says yes, then it would be the first sanctioned alternative to Viagra.
Unlike Viagra, which acts directly on blood flow in the penis, Uprima sparks an erection by stimulating a brain chemical involved in arousal. That molecule, dopamine, is also important in motor diseases, particularly Parkinson's. In fact, Uprima was initially investigated as a possible Parkinson's drug.
While the FDA isn't bound by its panel's decisions, the agency typically follows them. Approval of the new drug, which is made by TAP Holdings, a joint venture of Takeda Chemical Industries and Abbott Laboratories, could come by summer.
"Viagra doesn't work for everyone, so new products could be very helpful," says Dr. Ira Sharlip, a San Francisco urologist. He called Uprima "a worthwhile addition to the armamentarium" of treatments for erectile dysfunction.
At least 10 million American men have some degree of erectile dysfunction, the result of physical, emotional or undetermined causes. While some may have permanent disability, experts say the vast majority can get help.
The most sensational treatment is undoubtedly Viagra, Pfizer's little blue blockbuster that hit the market two years ago. Six million men have received 17 million prescriptions -- not to mention untold numbers of stand-up comics seeking a cheap laugh.
Effective in 60 percent of patients
Dr. Eugene Dula, a Van Nuys, Calif., physician who led a large clinical study of Uprima, says the drug has been proven safe and effective in studies involving more than 2,000 men with both psychological and anatomical erectile woes.
"It was studied on all comers," says Dula, medical director for West Coast Clinical Research, which helps drug firms test their products.
Overall, studies show that Uprima is effective in about 60 percent of men who take it. That falls short of Viagra's record, which has been effective in four out of five men. The only men who aren't good candidates for the Uprima are those with serious physiological problems that prevent erection. "It can be tried on virtually anybody else," he says, including patients with diabetes and high blood pressure, who face a significantly elevated risk of erectile dysfunction.
In his study, men who took Uprima achieved erections that lasted, on average, about 13 minutes -- long enough, at any rate, to serve their purpose, says Dula. Side effects from the drug were generally minimal, although some patients did report a particularly unromantic one: mild to severe nausea.
Uprima could be an attractive option for men who can't take Viagra because of heart conditions.
Another key difference between the two compounds is that the newcomer dissolves under the tongue, meaning it takes effect in 15 to 20 minutes, compared to an hour for the older drug. That allows for more spontaneous lovemaking, Dula says.
"Men who fail treatment with one oral agent can try the other," says Dr. Drogo Montague, who directs the Cleveland Clinic Foundation's Center for Sexual Dysfunction. Some men will probably combine the two drugs. Montague, who has studied Viagra, says between 70 and 80 percent of patients new to the drug are helped by it.
The committee recommended that the drug be made available in 2 and 4 milligram doses, according to Kim Modory, a spokeswoman for TAP.
What To Do
Most men will suffer occasional bedroom failures throughout their romantic lifetimes. So if it happens to you, don't run to the doctor some chemical assistance. But if erectile problems begin to disrupt your ability to have a normal sex life, treatment could be necessary, Montague says.
Doctors stress that neither Uprima, should it be approved, nor Viagra, is intended for men without impotence. Lest you be tempted, says Montague, "there's no evidence that [either] is an aphrodisiac that enhances the sexual experience."
Try this HealthSCOUT story about potential complications in men who take Viagra. No question, though, the drug was a major hit. Read this 1998 HealthSCOUT article on how it was so popular that its maker, Pfizer Inc., had to sue companies selling sound-alike knockoffs.
To learn more about erectile dysfunction, check out the Doctor's Guide online.
