LTR Pharma (ASX:LTP) said that interim phase two pharmacokinetic and safety data for its intranasal spray for erectile dysfunction, SPONTAN, showed a rapid time to peak concentration and a consistent safety profile, according to a Friday Australian bourse filing.
The study characterized the key pharmacokinetic parameters requested by the US Food and Drug Administration (US FDA), including rapid absorption, repeat-dose behavior, and consistency across adult and geriatric populations. The data support its planned FDA 505(b)(2) regulatory pathway, subject to completion of final statistical analysis, per the filing.
SPONTAN (five milligrams) demonstrated a median Tmax of 10 minutes, compared with a median Tmax of 60 minutes for the 20mg vardenafil oral tablet. The Tmax range for SPONTAN was 10 minutes to 15 minutes,
compared with 30 minutes to 180 minutes for the oral tablet.
Pharmacokinetic profiles in subjects aged over 65 years were comparable to those in the adult cohort, with no apparent differences observed in the dataset. Intranasal administration of SPONTAN over five consecutive days did not result in drug accumulation.
No serious or severe treatment-emergent adverse events were observed, per the filing.
Its shares rose 28% in recent trading on Friday.