LTR Pharma has received the final Clinical Study Report for its SPONTAN® Phase II pharmacokinetic study. The report completes the pharmacokinetic dataset agreed with the FDA for LTR Pharma’s planned U.S. 505(b)(2) submission.
LTR’s SPONTAN® is a fast-acting intranasal spray for the treatment of erectile dysfunction, enabling an onset of action in 10 minutes or less.
Prepared by independent CRO Southern Star Research, the report confirms the interim results announced on 1 May with full statistical analysis:
- SPONTAN absorbs six times faster than oral vardenafil tablets (median 10 minutes versus 60 minutes, p<0.0001)
- Predictable exposure: SPONTAN 5 mg, a quarter of the oral dose, produced approximately a quarter of the total exposure of the 20 mg tablet
- Five days of once-daily dosing showed no drug accumulation
- Comparable pharmacokinetics in men aged 65 and over, a key FDA requirement
- No serious adverse events, no Grade 3 or higher events and no discontinuations
LTR Pharma Chief Medical Officer, Professor Geoffrey Strange, said:
“The final report confirms the interim analysis and is consistent with the rapid absorption we demonstrated in our Phase I study. A median time to peak concentration of 10 minutes at a quarter of the oral dose, with no accumulation on repeat dosing and comparable pharmacokinetics in men aged 65 and over, gives us a complete, well-characterised pharmacokinetic picture. These results strongly support SPONTAN’s positioning as a rapid-onset, on-demand therapy.”
LTR Pharma Executive Chairman, Lee Rodne, said:
“We now hold a complete, independently reported dataset, designed to FDA specifications, confirming SPONTAN’s rapid-onset profile and favourable safety, with comparable pharmacokinetics in men aged 65 and over. This is the evidence package U.S. licensing partners and regulators need to see.”
With the pharmacokinetic dataset complete, the U.S. development programme moves to the submission-enabling workstreams scheduled for 2H CY2026.