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TAP Uprima

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Urologics Subcommittee of FDA's Reproductive Health Drugs Advisory Committee recommends approval of TAP's Uprima (apomorphine) April 10 based on six Phase III studies in 2,103 patients with erectile dysfunction (ED). The subcommittee unanimously recommended the 2 mg dose, which showed a 44% to 47% success rate for the primary endpoint - the percentage of attempts resulting in an erection firm enough for intercourse - compared to 32-38% for placebo. The subcommittee voted nine to three to recommend the 4 mg dose, which showed a success rate of 52-56% vs. 31-35% for placebo. Safety of the higher dose was a concern for the committee, which noted that there was limited testing among diabetics. The committee recommended a boxed warning against the use of alcohol and nitrates. Four studies showed greater drops in blood pressure for subjects using Uprima with alcohol, and adverse reactions were seen in 25 to 30% of subjects when the drug was paired with nitrates. In addition, the committee recommended that labeling reflect the fact that the Uprima trials excluded patients suffering from complete ED (those who did not have a normal nocturnal penile tumescence)

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