SPONTAN® Phase II interim data demonstrates rapid onset and pharmacokinetic profile addressing FDA Pre-IND requirements across adult and ≥65 populations
- Written by PR Newswire
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 profile, with no drug accumulation observed, and consistent pharmacokinetics across adult and...
