LTR Pharma has today announced that all patients recruited for its pivotal bioequivalence clinical study of SPONTAN® nasal spray have now received their second and final dose, completing the recruitment and dosing stage of the clinical study.
The Study is evaluating the relative bioavailability of SPONTAN, a novel and proprietary PDE5 nasal spray treatment compared to oral administration of Vardenafil, a widely used PDE5 oral tablet.
With recruitment and dosing now complete, the Study will progress to the data evaluation phase, with a data read-out expected in mid-2024. This data will be used to support pre-submission meetings with the FDA and prescriptions of SPONTAN via the early access scheme in Australia.
LTR Pharma Chairman, Lee Rodne, said:
“With recruitment and dosing now complete, we thank the participants and our partners for contributing to this critical study. We are the first and only nasal spray coming to market for the treatment of Erectile Dysfunction and are extremely excited to bring this key innovation to men worldwide. We are now entering the data analysis phase. We believe SPONTAN represents a large paradigm shift in the treatment for erectile dysfunction and is a disruptor to the global blockbuster PDE5 (Viagra, etc) market.”