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New Drug Application for Sexual Function Drug Uprima Withdrawn

On June 30, 2000, TAP Pharmaceuticals withdrew its New Drug Application (NDA) for Uprima from the FDA approval process. Uprima is a fast-acting drug that has shown promise in assisting some men with erectile dysfunction to achieve and maintain an erection. Uprima previously passed the FDA review board’s meeting in the spring of 2000.

Commenting on the decision, TAP spokesperson Kimberly Modory told HHH: “The FDA did not disapprove the drug. Rather, we withdrew our application prior to FDA action. We knew the FDA had questions and we wanted to talk to them further to understand their concerns and be responsive to them. We hope to be able to resolve these concerns in meetings with the FDA within the next few weeks.”

According to Modory, The FDA has already reviewed the data from clinical trials in which patients were administered two, four, five and six milligram doses of Uprima. Additional clinical trial data, which TAP has submitted to the FDA, covers clinical trials in which patients received doses at home of two, three and four milligrams of the drug, as well as other data

Uprima works within 10 to 25 minutes for most men. Unlike other erectile dysfunction drugs Uprima is not swallowed, but placed under the tongue, where it is rapidly absorbed into the blood stream and works centrally in the brain to promote the natural erectile function.

Uprima has been widely evaluated in tests and clinical trials conducted since 1996. More than 3,800 patients received in excess of 112,000 doses of the drug in 28 different studies. The most common side effect was nausea, which was seen in approximately 2.6% of men receiving two milligrams and 20.7% of men who initially received four milligram doses.

Because of the nausea problem, TAP authorized an “In-home Dosing Study” on 849 patients, which was conducted from September to November of 1999. The doses were then gradually increased to the four milligram level. With the gradual titration process, nausea was reduced to 12.4%. The nausea was mild and was limited to the first few doses, after which it usually disappeared. Less than 1 percent of those tested quit the In-home Dosing Study because of nausea.

TAP will be receiving information from the FDA that may include the need for further testing in clinical trials. The FDA is most likely concerned with the potential problems of lightheadedness and dizziness and the potential of lowering the blood pressure. In the In-home Dosing Study, the incidence of dizziness was reported in only 0.4% of men.

A limited number of men taking nitrates for coronary heart disease also were evaluated. There were no untoward adverse events in these men who also received Holter Monitor testing to evaluate their cardiac rhythms.

Modory told hisandherhealth: “We know patients want Uprima and we are doing all that we can to get it to them, but we must first assure that it is both safe and effective.”

I also have learned that a new study of Uprima will be launched in the near future, perhaps as early as fall 2000. The study will assess the effectiveness of Uprima and Viagra when the two drugs are taken in combination.

In the upcoming study, one group of patients will receive Uprima and a placebo, while another group will receive a two or four milligram dose of Uprima in combination with 25 or 50 milligrams of Viagra.

The study will be conducted at approximately 70 sites, nationwide, and will involve about 420 patients.

(Note: Dr. Auerbach, a board-certified urologist, does field research drug testing for pharmaceutical companies, including the manufacturers of Uprima.)