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...

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