Drugmaker Pulls Impotence Drug out of FDA Approval Process
But the delay does not necessarily mean Uprima will not eventually be approved. "We are still very confident [that Uprima is a safe and effective drug]. We hope by taking this extra time we will have a much a stronger product," Kim Modroy, a spokesperson for TAP Pharmaceuticals, tells WebMD.
The additional trials now underway include a large, placebo-controlled study to determine safety and effectiveness in doses ranging from 2 mg to 4 mg, and a smaller placebo-controlled trial to study 3 mg and 4 mg doses. Earlier trials tested a 5 mg dose. The additional trials also include studies to assess how the drug interacts with alcohol and nitrates.
These new studies should answer any of the agency's concerns, notes Dula, who has participated in a number of studies of Uprima.
Modroy says that the company expects to finish these studies sometime this summer and that over the next few weeks, TAP also plans to discuss with FDA officials a new timetable for Uprima's review.
Uprima does appear to be safer than Viagra for patients with heart disease, based on studies that show its heart-related side effects are much milder than those seen with Viagra, notes Dula.
"It is important with Uprima, as with any other drug, that the patient be counseled. It's not candy," he tells WebMD. However, with appropriate follow-up, "I think both Uprima and Viagra are safe and effective first-line treatments."
In previous clinical trials submitted for Uprima's approval, commons side effects included nausea (32%), dizziness (15%), and sweating. About 60% of the participants dropped out due to these side effects, but the majority of these patients were taking a 5 mg dose, which is a dosing regimen that TAP says it has no plans to pursue. If it is eventually approved, Uprima will be sold in doses ranging from 2 mg to 4 mg, the company says.