LTR Pharma (ASX:LTP) has announced that clinical data from its Phase 1 pharmacokinetic study of SPONTAN (SDS-089), the company's lead intranasal vardenafil formulation for erectile dysfunction (ED), has been published in the peer-reviewed European Journal of Pharmaceutical Sciences.
The company said that the publication provides independent validation of SPONTAN's differentiated profile, showing peak plasma concentrations in approximately 10 minutes versus 45 minutes for conventional oral tablets.
The European Journal of Pharmaceutical Sciences is a leading international peer-reviewed journal that publishes high-impact research in pharmaceutical sciences and drug delivery.
LTR Pharma said the randomised, crossover study in 18 healthy male volunteers compared SPONTAN nasal spray with oral vardenafil tablets.
Professor Geoff Strange, LTR Pharma's Chief Medical Officer, said, "This peer-reviewed publication in a leading European journal provides robust scientific validation of SPONTAN's game-changing pharmacokinetic profile. The data clearly demonstrate that our intranasal delivery technology achieves the desired therapeutic levels in under 10 minutes – addressing the spontaneity challenge that drives part of the 50 per cent of patients discontinuing oral ED treatments within their first year. From a clinical perspective, this represents a fundamental advancement in how PDE5 inhibitors can be administered, with the potential to significantly improve treatment adherence and patient satisfaction."