A new pill called Uprima, though seen as having some undesirable side effects, moved a step closer Monday to becoming the first rival to the wildly popular Viagra as a possible oral treatment for impotence.
An advisory committee recommended that the Food and Drug Administration (FDA) approve the relatively fast-acting Uprima for treating erectile dysfunction, a condition that affects an estimated 30 million American men over age 40.
The FDA usually follows its panels' advice and is expected to decide by July whether Uprima, made by Illinois-based TAP Pharmaceuticals, can be sold in the United States. The panel's support, however, came with conditions that the manufacturer provide strong warnings to patients about possible serious side effects, including fainting, nausea and interactions with alcohol.
Dr. Peter Kowey, a panel member and a cardiologist at Lankenau Hospital and Medical Research Center in Wynnewood, Pennsylvania, said he favored a warning "in bold letters that says if you take this drug you may pass out." He added: "The complications seen with this drug are frightening."
More men than ever are seeking a medical remedy for impotence since Viagra, made by Pfizer Inc, hit the market 2 years ago with the promise of being the first oral drug that could help men rediscover their lost sex lives.
Viagra, too, has a dangerous side effect, a possibly deadly interaction with heart drugs known as nitrates. But a massive advertising campaign, including former presidential candidate Sen. Bob Dole urging men to pursue treatment for a condition often embarrassing to discuss, helped Viagra sales top $1 billion last year.
While Viagra revenue is expected to grow this year, Uprima sales are expected to be more moderate at about $100 million to $300 million a year, pharmaceutical industry analysts have said.
Uprima does offer some unique advantages, according to officials with TAP, a joint venture between Abbott Laboratories and Takeda Pharmaceuticals.
A pill that is absorbed under the tongue, Uprima works by stimulating production of the brain chemical dopamine, which sends a signal for an erection. Viagra, by contrast, is swallowed and increases blood flow to the penis.
In three clinical trials of men with varying degrees of impotence, Uprima took effect in as little as 15 minutes. It helped produce an erection sufficient for intercourse about 44% to 56% of the time, according to TAP executives and consultants, who said patients needed alternatives to Viagra.
"Current therapies are limited. No drug is effective for all patients," said Dr. James Freston of the University of Connecticut Health Center, a TAP consultant.
About 15% of patients suffered from nausea, the most frequent side effect.
