Uprima Withdrawn from FDA consideration

WASHINGTON (AP) -- Uprima's application was pulled from government approval. This upcoming impotence drug from TAP Pharmaceuticals was once expected to be the first real competitor of Pfizer's Viagra after FDA advisers recommended the drug for approval last April.

However, these same advisers now warn that the drug can cause a serious side effect: "One in 30 men who tested the optimal dose fainted or suffered severe low blood pressure. One man crashed his car; another fell and fractured his skull."

FDA's deadline was June 30th to decide whether to allow the sale of the drug with strict label warnings, reject it or require more safety studies. But before the government could reach any type of decision, TAP Pharmaceuticals announced that it was withdrawing Uprima's FDA application for approval.

"We knew they had questions," acknowledged TAP spokeswoman Kim Modory.

However, TAP stands steadfastly by Uprima's side emphasizing the efficacy of the drug and assuring the public that it will most certainly seek for approval from the FDA as soon as new clinical data is available.

"TAP is very committed to patient care, and it is our hope that by taking the extra time to submit additional data, TAP will be able to provide a treatment with an even stronger product profile," TAP president Thomas Watkins said in a statement.

Dr. Sidney Wolfe of Public Citizen countered this by calling it "inconceivable" that the dangers of Uprima will be disproved by additional study results. "If this company is smart it will permanently kill this drug," he said. "This drug is just unacceptably dangerous and barely effective."

When Viagra came out in 1998, it became the first oral treatment for impotence. And the popularity of Uprima is due to the fact that although some 30 million men are afflicted with impotence, many weren't helped by Viagra.

Uprima Side Effects

Uprima Mechanism of Action

Graphics from FDA Hearing (ppt)