Zonagen/Schering Plough Vasomax

Executive Summary

U.K. Medicines Control Agency suspension of clinical trials for phentolamine lifted, Vasogen says. Trials for the erectile dysfunction treatment were put on hold following the findings of brown fat proliferation in a two-year rat carcinogenicity study. Vasogen said the U.K. agency's letter allows for evaluation of clinical results. In May, FDA put a partial hold on the conduct of clinical trials. The agency asked for another two-year rodent study to be conducted. The Vasomax NDA received a "non-approvable" letter in May 1999