LTR Pharma Limited has now moved into the data analysis stage of its clinical trial for Spontan, a nasal spray aimed at treating erectile dysfunction (ED).
The new phase follows the completion of recruitment and dosing in the trial, testing an approach that offers a quick remedy for ED symptoms, with effects starting within 10 minutes of application (PD 20 Feb).
The study compares the bioavailability of Spontan with that of orally taken Vardenafil, a recognised PDE5 inhibitor, to highlight the advantages of the product's nasal delivery.
With data analysis underway, results are anticipated by mid-2024, setting the stage for discussions with regulatory bodies, and a potential market introduction via Australia's early access scheme.
Lee Rodne, Chairman of LTR Pharma, shared his enthusiasm about entering this data analysis phase, thanking participants and partners for their roles in the study.
"We believe Spontan represents a large paradigm shift in the treatment for ED and is a disruptor to the global blockbuster PDE5 (Viagra, etc) market," said Rodne.
"We are the first and only nasal spray coming to market for the treatment of ED and are extremely excited to bring this key innovation to men worldwide."
The findings will play a vital role in the pre-submission meetings with the US FDA and the introduction of Spontan into the market through Australia's early access scheme. JG
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