FDA requests more Vasomax data

Zonagen (ZONA) said the FDA has said an additional animal study will be required before the agency will consider the approval of Vasomax phentolamine to treat erectile dysfunction. The FDA recommended that Zonagen (ZONA) conduct another two-year rodent study due to brown fat proliferation seen in an earlier two-year rat study. In 1999, the FDA placed ZONA's phentolamine-based compounds on clinical hold pending resolution of safety issues raised by these results (see BioCentury, Aug. 16, 1999). ZONA said it intends to exercise its right of appeal. ...