Jury Still Out on Uprima’s Future

The future for Uprima, a long-awaited impotency medication expected to rival Viagra, looks murky after clinical trials last summer raised questions about its safety.

The drug, manufactured by TAP Pharmaceutical Products Inc., was expected to be approved by last July. Company officials will now say only that they are conducting further studies and “working with the Food and Drug Administration” to determine when they should apply for approval to sell the drug in the United States.

TAP withdrew its original application in June when several men participating in clinical trials fainted due to severe low blood pressure. The consumer advocacy organization Public Citizen has lobbied against approval of Uprima due to safety concerns.

Meanwhile, last month Uprima received a so-called positive opinion from the European Union’s Committee for Proprietary Medicinal Products, a step that clears the way for the drug to be marketed in Europe.

Final approval to sell Uprima in Europe is expected in May, according to Abbott Laboratories, which holds the rights to market Uprima outside the United States and Canada.

Uprima, or apomorphine, is considered to be a promising treatment for erectile dysfunction because it works differently than Viagra and possibly could be used with that drug. While Viagra works by increasing blood flow to the penis, Uprima works in the brain to cause erections.

Uprima is a tablet that is dissolved under the tongue. Studies have shown that many patients taking it achieve an erection within 20 minutes. Viagra sometimes takes longer to work.