Patient Recruitment Commences for SPONTAN® Pivotal Clinical Study

LTR Pharma has today announced patient recruitment has commenced for its pivotal bioequivalence clinical study for SPONTAN®, a fast-acting, on-demand Nasal Spray treatment for Erectile Dysfunction (ED).

The Study will assess the relative bioavailability of Vardenafil following administration of SPONTAN nasal spray, when compared to oral delivery of Vardenafil tablets – a widely used PDE5 inhibitor.

The study will be conducted in Sydney in partnership with Southern Star Research and Scientia Clinical Research. Data from the study to be used in SPONTAN’s regulatory submissions.

LTR Pharma Chairman, Lee Rodne, said:

“This Study will form a critical piece of the data package we plan to submit to the FDA and TGA – supporting our plans for expedited regulatory approval for SPONTAN in key initial markets. We believe SPONTAN has the potential to disrupt the global blockbuster PDE5 market and we are excited to bring this innovation to men worldwide. I encourage all members of the public who meet the essential recruitment criteria to get involved.”

The global ED market is forecast to increase to $5.94 billion by 2028. In Australia, over 60% of males suffer from ED once they reach the age of 45 years or older.

Click here to read the ASX release.