Melbourne, Australia – LTR Pharma Limited (ASX:LTP), a leading pharmaceutical company, is excited to announce the successful completion of recruitment and dosing phases in its pivotal clinical study of SPONTAN®, a revolutionary nasal spray designed to treat erectile dysfunction (ED). This marks a significant milestone in the development of SPONTAN, setting the stage for a mid-2024 data read-out.
SPONTAN represents a world-first in ED treatment, offering a fast-acting, on-demand solution for those affected by this condition. Unlike traditional oral tablets, SPONTAN’s innovative nasal delivery technology ensures rapid absorption, bypassing the digestive system and providing a significantly faster onset of action within 10 minutes.
The study focused on evaluating the relative bioavailability of SPONTAN compared to the oral administration of Vardenafil, a widely recognized PDE5 inhibitor. This comparison is crucial in demonstrating the unique benefits and effectiveness of SPONTAN as a novel treatment option for ED.
With the recruitment and dosing stages now behind, the company has commenced the data analysis phase. The results from this study are eagerly anticipated and are expected to be released in mid-2024. These findings will play a vital role in the pre-submission meetings with the FDA and the introduction of SPONTAN into the market through Australia’s early access scheme.
LTR Pharma is committed to revolutionizing the treatment of ED and improving the quality of life for individuals affected by this condition. The completion of this phase brings us one step closer to making SPONTAN available to those in need, offering a discreet, efficient, and innovative solution to ED.
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.”
About us:
LTR Pharma is focused on improving men’s health, physically and mentally, through the commercialisation of an innovative nasal spray treatment for Erectile Dysfunction. ED is a pressing health issue for millions of men that can negatively impact self-esteem and relationships, across multiple age brackets. LTR Pharma’s lead product SPONTAN® is set apart from existing ED therapies by its mechanism of action – intranasal delivery technology of a PDE5 inhibitor. The nasal cavity is a highly vascular part of the body supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less. LTR Pharma is proudly aiming to restore greater control over the timing, spontaneity, and enjoyment of sexual experiences.
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Jane Morgan
