LTR Pharma (ASX:LTP) has announced that the first patients have completed the first dosing in its pivotal bioequivalence clinical study of SPONTAN nasal spray.
LTR Pharma is developing and commercialising SPONTAN as an innovative nasal spray treatment for erectile dysfunction (ED).
The company said the study will evaluate the relative bioavailability of SPONTAN, a novel and proprietary PDE5 nasal spray.
This nasal spray will be compared to the oral administration of vardenafil, a widely used PDE5 oral tablet.
LTR Pharma chair Lee Rodne said, "The study is off to a great start, and we are grateful to the participants interested in entering the study. SPONTAN nasal spray represents a potential paradigm shift in the treatment for erectile dysfunction and is a promising disruptor to the global blockbuster PDE5 market, offering a discreet and efficient treatment alternative. We are excited to bring this key innovation to men worldwide.”
The study is an 18-patient single-dose, randomised, open-label, two-treatment, two-period crossover study of SPONTAN nasal spray compared to Vardenafil tablets in healthy adult male subjects under fasting conditions.