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Abstracted from Reuters
from an article By Daniel Bases
Zonagen Requests Delay in FDA Hearing for Vasomax
NEW YORK, May 10 (Reuters) -- Drug maker Zonagen Inc. said on Monday it would forego a scheduled June U.S. Food and Drug Administration panel review of its male impotence drug, Vasomax. Zonagen said that after talking with its marketing partner, Schering-Plough Corp. it decided it needed more efficacy data to make Vasomax more marketable upon potential FDA approval.
This announcement is important because it means a delay in the much-anticipated appearance of a second oral agent (after Viagra) for male erectile dysfunction. The Woodlands, Texas-based company said it asked the FDA to give it more time to collect data. But the FDA rejected that request. The company said that since it did not yet submit the data, it now expects to receive a non-approvable letter from the FDA on Vasomax within the next few days.
The company said that additional studies were going to be conducted and paid for by Schering-Plough, and an amendment to the original NDA ("New Drug Application") is expected to be submitted to the FDA by late 1999, with a panel review most likely in June 2000.
The delay of Vasomax opens the door for Uprima, an oral M.E.D. medication that targets the brain rather than the peripheral nervous system like Viagra does. Uprima is made by TAP Pharmaceuticals, a joint venture between Takeda Chemical Industries of Japan and Abbott Laboratories Inc. In fact, data from three Phase III Uprima studies presented earlier this month at the American Urological Association meeting in Dallas, TX., suggest that the sublingual apomorphine tablets can increase the number of successful intercourse attempts. Uprima is a central initiator that works by stimulating an erection through mechanisms originating in the brain.