Drugmaker Pulls Impotence Drug out of FDA Approval Process
Eugene Dula, MD, a urologist and director of West Coast Clinical Research in Van Nuys, Calif., tells WebMD that erectile dysfunction is associated with a high placebo response, and as a result, concerns regarding whether it was tested in the right patient population are probably unfounded.
When asked why the committee voted to support approval in spite of the potential for serious side effects and questions about effectiveness, FDA Committee Chair Ricardo Azziz, MD, MPH, told WebMD, "[Erectile dysfunction] is a major quality of life issue."
Now experts speculate the company withdrew its application because of chances that the FDA might not follow its committee's recommendations to approve the drug. Whatever the outcome, Uprima's interactions with nitrates and alcohol are risks that need serious consideration, Marianne Mann, MD, a deputy director for the FDA, told committee members at the April meeting.
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."