SPONTAN® Phase II interim data demonstrates rapid onset and pharmacokinetic profile addressing FDA Pre-IND requirements across adult and ≥65 populations
Highlights Median Tmax of 10 minutes for SPONTAN ® (5 mg) versus 60 minutes for oral vardenafil (20mg), consistent with Phase I study. Interim data provide the key pharmacokinetic dataset requested by the FDA, including rapid absorption, repeat-dose...