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Zonagen/Schering-Plough Vasomax

Executive Summary

FDA places hold on clinical trials of Vasomax (phentolamine) pending analysis of data from a two-year rat carcinogenicity study, expected to be completed in the fourth quarter. Preliminary findings show a high proliferation of "brown fat" in the rats. A fully enrolled, 12-week Schering study of Vasomax for erectile dysfunction has been permitted to continue. Another proposed 12-week Schering study and a Zonagen Phase II trial of phentolamine for female sexual dysfunction are being placed on hold. The companies anticipate the hold will cause a six-month delay in regulatory filing
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PS034698

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